Drug Approvals Monthly Update: August 2024

This monthly update of United States (U.S.) Food and Drug Administration (FDA) approvals provides a review of newly approved specialty drugs, new indications and recent first-time generic launches.

Specialty

New drugs

07/25/2024 Leqselvi™ (deuruxolitinib)

The FDA has approved Sun’s Janus kinase (JAK) inhibitor, Leqselvi™, for the treatment of adults with severe alopecia areata. Leqselvi™ carries a limitation of use stating it is not recommended for use in combination with other JAK inhibitors, biologic immunomodulators, cyclosporine or other potent immunosuppressants. It is approved as oral tablets to be taken twice daily. Two randomized, double-blind, placebo-controlled, phase 3 clinical trials evaluating more than 1,200 adults (THRIVE-AA1, THRIVE-AA2) demonstrated a statistically significant improvement in the proportion of patients with a Severity of Alopecia Tool (SALT) score ≤ 20 (≥ 80% scalp hair coverage) at week 24 with Leqselvi™ compared to placebo.^1,2 Leqselvi™ is expected to compete with other similar agents indicated for severe alopecia areata: baricitinib (Olumiant®) and ritlecitinib (Litfulo™). Like other JAK inhibitors, Leqselvi™ carries a black box warning for serious infections, mortality, malignancy, major adverse cardiovascular events (MACE), and thrombosis. Launch timeframe is to be determined, with pricing to follow.

07/26/2024 Erzofri® (paliperidone palmitate)

Luye Innomind’s 505(b)(2) New Drug Application (NDA) approval for an extended-release (ER) injectable suspension of paliperidone palmitate, Erzofri®, has been approved. Erzofri® is an atypical antipsychotic indicated for: (1) the treatment of schizophrenia in adults and (2) the treatment of schizoaffective disorder in adults as monotherapy and as an adjunct to mood stabilizers or antidepressants. It will be supplied as an ER injectable suspension in the following strengths: 39 mg/0.25 mL, 78 mg/0.5 mL, 117 mg/0.75 mL, 156 mg/mL, 234 mg/1.5 mL, and 351 mg/2.25 mL. Erzofri® is administered by a health care professional (HCP) and is given as an initial intramuscular (IM) loading dose administered into the deltoid, followed by monthly IM injections into the deltoid or gluteal muscle. Before starting therapy with Erzofri®, tolerability with oral paliperidone or oral risperidone should be established for patients naïve to oral/injectable paliperidone or risperidone. Approval was based on studies of another once-a-month paliperidone palmitate ER injectable suspension.³ Erzofri® is expected to compete with the other long-acting injectable (LAI), paliperidone palmitate (Invega Sustenna®), that is also dosed monthly and shares its indications. Availability of Erzofri®, as well as pricing information, is forthcoming.

08/01/2024 Tecelra® (afamitresgene autoleucel)

The FDA has granted Accelerated Approval to the Biologics License Application (BLA) for Adaptimmune’s Tecelra®, a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T cell immunotherapy. Approval marks the first T cell receptor (TCR) gene therapy to receive FDA approval and the first new treatment option for individuals with synovial sarcoma in greater than a decade. Tecelra® is indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are human leukocyte antigen (HLA)-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive, and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or -cleared companion diagnostic devices. As this was an Accelerated Approval, continued approval may require demonstration of benefit in confirmatory clinical trial(s). Product will be available as a cell suspension for autologous use as a one-time intravenous (IV) infusion administered by an HCP. A lymphodepleting chemotherapy regimen is required prior to administration. The agent requires special storage and handling and is prepared for the patient and directly shipped to the healthcare facility in the vapor phase of a liquid nitrogen shipper. Due to the agent’s black box warning for cytokine release syndrome (CRS), HCPs should have immediate access to medications and resuscitative equipment for the management of CRS. The multicenter, open-label, SPEARHEAD-1 clinical trial (n=44) demonstrated Tecelra® had an overall response rate (ORR) of 39% after a median follow-up time of 32.6 months.⁴ The agent was reviewed under the Priority Review pathway and received Orphan Drug and Regenerative Medicine Advanced Therapy (RMAT) designations. Tecelra® may compete with the oral kinase inhibitor pazopanib (Votrient®) that is indicated for the treatment of adults with advanced soft tissue sarcoma who have received prior chemotherapy. The average wholesale price (AWP) for the single dose gene therapy is $872,400. Tecelra® is anticipated to be available at six to ten authorized treatment centers this year.

08/06/2024 Voranigo® (vorasidenib)

The FDA has approved the isocitrate dehydrogenase-1 (IDH1) and isocitrate dehydrogenase-2 (IDH2) inhibitor Voranigo® for adult and pediatric patients ≥ 12 years old with grade 2 astrocytoma or oligodendroglioma with a susceptible IDH1 or IDH2 mutation, following surgery including biopsy, sub-total resection, or gross total resection. Voranigo® is supplied in 10 mg and 40 mg oral tablets for once daily dosing that is continued until disease progression or unacceptable toxicity. The double-blind, randomized, phase 3 INDIGO clinical trial (n=331) demonstrated a significant improvement in progression-free survival (PFS) with Voranigo® compared to placebo (median PFS, 28 months versus 11 months, respectively; hazard ratio, 0.39; p<0.001).⁵ Servier’s Voranigo® is the first targeted therapy approved specifically for grade 2 IDH-mutant glioma. Ivosidenib (Tibsovo®) is an off-label systemic therapy option for patients with IDH1 mutant astrocytoma or oligodendroglioma. Voranigo® was approved under the Priority Review pathway and was granted Breakthrough Therapy, Fast Track, and Orphan Drug designations.  Voranigo® is commercially available and carries an AWP for a 30-day supply is $47,857.20.

08/07/2024 Lymphir™ (denileukin diftitox-cxdl)

Citius’ interleukin-2 (IL2)-receptor-directed cytotoxin, Lymphir™, has received FDA approval for the treatment of adults with relapsed or refractory stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. Product will be supplied as a 300-mcg lyophilized cake in a single-dose vial for reconstitution and further dilution. Dosage is based on actual body weight and is given as an IV infusion on days 1 through 5 of a 21-day cycle; treatment is continued until disease progression or unacceptable toxicity. Approval was based on the open-label, single-arm, multicenter, phase 3 study 302 (n=69) that demonstrated a median time to response of 1.4 months and an objective response rate of 36% (complete response, 9%) in this heavily pre-treated patient population with a median of 4 prior therapies.⁶ Lymphir™ received Orphan Drug designation for this BLA. Several systemic therapies have demonstrated efficacy in patients with advanced CTCL, and the following agents are FDA-approved for common CTCL subtypes (e.g., mycosis fungoides, Sézary syndrome): bexarotene (Targretin®), brentuximab vedotin (Adcetris®), mogamulizumab-kpkc (Poteligeo®), vorinostat (Zolinza®), and romidepsin (Istodax®). However, Lymphir™ is the only CTCL therapy targeting the IL-2 receptor found on malignant T-cells and immunosuppressive regulatory T lymphocytes. Lymphir™ carries a black box warning for capillary leak syndrome, including life-threatening or fatal reactions. The product is a reformulated version of denileukin diftitox (Ontak®), a previously marketed agent that was voluntarily withdrawn in 2014. Launch of Lymphir™ is expected within 5 months of approval with pricing to follow.

08/09/2024 Yorvipath® (palopegteriparatide)

The FDA has granted approval to Ascendis for Yorvipath®, a parathyroid hormone analog (PTH[1-34]) indicated for the treatment of hypoparathyroidism in adults. This prodrug of parathyroid hormone carries limitations of use stating it has not been studied for acute post-surgical hypoparathyroidism, and the titration scheme was only assessed in adults who first achieved an albumin-corrected serum calcium of ≥ 7.8 mg/dL using calcium and active vitamin D treatment. Yorvipath® will be supplied as a 300 mcg/mL concentration of teriparatide in three different sizes of single-patient-use, prefilled pens to accommodate individualized once daily subcutaneous (SC) doses ranging from 6 mcg to 30 mcg based on serum calcium. Dosing is titrated to maintain serum calcium within the normal range without needing active vitamin D (e.g., calcitriol) or therapeutic calcium (elemental calcium > 600 mg/day); calcium supplementation adequate to meet daily dietary requirements can be continued. The agent can be injected by patients or caregivers following proper training. Yorvipath® received Priority Review and was granted Orphan Drug designation from the FDA. Results from the 26-week, randomized, double-blind PaTHway trial (n=84) demonstrated that significantly more patients who received Yorvipath® (79%) than patients who received placebo (5%) achieved the primary composite efficacy endpoint (p < 0.0001); this endpoint included normal serum calcium levels, independence from conventional therapy, and stable dose.⁷ By the end of 2024, the parathyroid hormone (Natpara®) will be discontinued, thereby resulting in Yorvipath® being the only hormonal replacement therapy indicated to treat hypoparathyroidism in the U.S. Yorvipath® is anticipated to be available sometime between the fourth quarter of 2024 and first quarter of 2025 with pricing to follow.

08/12/2024 Nemluvio® (nemolizumab-ilto)

Galderma’s Nemluvio®, an interleukin (IL)-31 receptor antagonist, has received FDA approval for the treatment of adults with prurigo nodularis. Nemluvio® is administered SC as an initial loading dose, followed by maintenance dosing every 4 weeks. Patients or their caregivers can administer SC injections following proper training. Product will be supplied in single-dose, prefilled dual chamber pens containing lyophilized powder and water for injection as diluent. Approval was based on two randomized, double-blind, placebo-controlled, phase 3 studies (OLYMPIA 1 and OLYMPIA 2; n=560 total) that demonstrated significant improvements over placebo in the co-primary efficacy endpoints assessing itch reduction (Peak Pruritus Numerical Rating Scale) and skin clearance (Investigator’s Global Assessment).^8,9 Nemluvio® received Breakthrough Therapy designation and Priority Review. It is the first monoclonal antibody that inhibits IL-31 signaling and is expected to compete with dupilumab (Dupixent®), an IL-4 receptor antagonist also indicated for adults with prurigo nodularis. Nemluvio® is commercially available and carries an AWP of $5,088 per autoinjector.

08/14/2024 Livdelzi® (seladelpar)

The FDA has granted Accelerated Approval to Gilead Sciences’ peroxisome proliferator-activated receptor (PPAR)-delta agonist, Livdelzi®, indicated for the treatment of primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA. The Accelerated Approval was based on a reduction in alkaline phosphatase (ALP), thereby improvement in survival or prevention of liver decompensation have not been demonstrated. Continued approval may require demonstration of benefit in confirmatory clinical trials. Livdelzi® carries a limitation of use stating it is not recommended in patients who have or develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy). Product is supplied as a 10 mg capsule that is taken orally once daily. Approval was based on the 12-month, double-blind, phase 3 RESPONSE trial (n=193) that demonstrated a significantly greater proportion of Livdelzi® patients than placebo patients achieved a biochemical response (61.7% versus 20%; difference, 41.7%; p<0.001).¹⁰ Livdelzi® was reviewed under the Priority Review pathway and received Breakthrough Therapy and Orphan Drug designations. Livdelzi® is the second oral PPAR agonist for PBC, following the approval of elafibranor (Iqirvo®). Obeticholic acid (Ocaliva®), an oral farnesoid X receptor (FXR) agonist, is also indicated for PBC. Livdelzi® is commercially available with an AWP for a 30-count bottle of capsules of $15,127.

08/14/2024 Niktimvo™ (axatilimab-csfr)

Incyte and Syndax have received FDA approval for the colony stimulating factor-1 receptor (CSF-1R)-blocking antibody, Niktimvo™. The new therapy is indicated for the treatment of chronic graft-versus-host disease (cGVHD) after failure of at least two prior lines of systemic therapy in adult and pediatric patients weighing ≥ 40 kg. Product will be supplied as a 50 mg/mL solution for injection in a single-dose vial with dosage based on body weight given every 2 weeks as an IV infusion over 30 minutes administered by an HCP. Efficacy and safety were based on the randomized, open-label AGAVE-201 study (n=79) that demonstrated an ORR within the first six months of treatment of 75% with all patients who responded having a partial response.¹¹ Niktimvo™ was reviewed under Priority Review and received Fast Track and Orphan Drug designations. The monoclonal antibody may potentially compete with other agents with similar indications specified in the guidelines as systemic treatment options for patients with refractory GVHD (e.g., ruxolitinib [Jakafi®], belumosudil [Rezurock®], ibrutinib [Imbruvica®]). Niktimvo™ is expected to be commercially available by early in the first quarter of 2025 with pricing to follow.

08/19/2024 Lazcluze™ (lazertinib)

The FDA has granted approval to Janssen’s Lazcluze™, a kinase inhibitor, indicated in combination with amivantamab-vmjw (Rybrevant®) for the first-line treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. Product is supplied as 80 mg and 240 mg oral tablets and is dosed orally once daily until disease progression or unacceptable toxicity. Approval was based on the randomized, phase 3 MARIPOSA trial that demonstrated Lazcluze™ in combination with Rybrevant® decreased the risk of disease progression or death by 30% compared to osimertinib (Tagrisso®) (median progression-free survival [PFS]: 23.7 months versus 16.6 months; p<0.001).¹² Lazcluze™ received Priority Review and provides a chemotherapy-free regimen with improved PFS compared to its competitor Tagrisso®. Product is commercially available and carries an AWP of $21,838 per bottle.

New biosimilars

07/19/2024 Epysqli® (eculizumab-aagh)

Epysqli®, from Samsung Bioepis, has been approved by the FDA as a biosimilar to Alexion’s Soliris® (eculizumab). This anti-C5 complement monoclonal antibody is approved for two of the reference product’s indications: (1) paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and (2) atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Unlike Soliris®, it is not approved for myasthenia gravis nor neuromyelitis optica spectrum disorder (NMOSD). Epysqli® and its reference product are also not approved for the treatment of patients with Shiga toxin Escherichia coli-related hemolytic uremic syndrome. Epysqli® is approved as a 300 mg/30 mL solution for injection in a single-dose vial and is administered IV, with dose and frequency based on the patient’s age and indication for use. This product is the second Soliris® biosimilar to be approved in the U.S. following the approval of eculizumab-aeeb (Bkemv™) in May 2024; Bkemv™ shares the same indications as Epysqli® but has been deemed  interchangeable with Soliris®. Like Soliris® and Bkemv™, Epysqli® carries a boxed warning for serious meningococcal infections and will only be available through a Risk Evaluation and Mitigation Strategies (REMS) program. Launch timeframe for Epysqli® is to be determined, with pricing to follow.

08/09/2024 Enzeevu™ (aflibercept-abzv)

The FDA has approved Sandoz’s Enzeevu™ as a biosimilar to Regeneron’s Eylea® (aflibercept). This vascular endothelial growth factor (VEGF) inhibitor is approved for the treatment of neovascular (wet) age-related macular degeneration (AMD); it is not approved for other Eylea® indications including macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and retinopathy of prematurity. Enzeevu™ is administered via intravitreal injection and will be available in the same presentations as reference product Eylea®, including a 2 mg (0.05 mL of 40 mg/mL) solution in a single-dose prefilled syringe and single-dose vial. Enzeevu™ is expected to compete with the other Eylea® biosimilars, aflibercept-yszy (Opuviz™), aflibercept-jbvf (Yesafili™), and recently approved aflibercept-mrbb (Ahzantive™). Opuviz™ and Yesafili™ have been deemed interchangeable with Eylea®, while Enzeevu™ has been provisionally determined to be interchangeable with the reference product as it is subject to an unexpired exclusivity for the first interchangeable biosimilar products. Launch timeframe for Enzeevu™ will depend on potential litigations or settlements, with pricing to follow.

New indications

07/18/2024 Xembify® (immune globulin subcutaneous, human-klhw)

The FDA has expanded the approval of Grifols’ Xembify® for the treatment of primary humoral immunodeficiency (PI) in patients ≥ 2 years of age to include use in treatment-naïve patients. For these patients, a weight-based loading dose should be administered for five consecutive days, followed by weekly dosing starting on day 8. Additionally, a biweekly dosing option has been approved for treatment-experienced patients switching from either an IV or SC immune globulin. Other previously approved dosing options for treatment-experienced patients include weekly dosing or frequent dosing (2 to 7 times per week). Xembify® is a 20% solution of purified human immunoglobulin that is patient-administered via SC injection, and dosing should be individualized based on each patient’s pharmacokinetic and clinical response.

07/22/2024 Kisqali® (ribociclib)

Novartis’ kinase inhibitor, Kisqali®, has received approval for its indication for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, in combination with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy, to be expanded to include all adult patients. Previously, Kisqali® was only approved for men and postmenopausal women for this indication. Men and pre- or perimenopausal women who are treated with Kisqali® should receive a luteinizing hormone-releasing hormone (LHRH) agonist according to current clinical practice standards. This drug also carries an indication for the treatment of adults with HR-positive, HER-2 negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy. For a complete treatment cycle, Kisqali® should be administered orally once daily for 21 consecutive days, followed by 7 days off treatment.

07/22/2024 Tofidence™ (tocilizumab-bavi)

Biogen’s Tofidence™, which is a biosimilar to Genentech’s Actemra®, has been approved by the FDA for the treatment of adults with giant cell arteritis (GCA) and for the  treatment of hospitalized adults with coronavirus disease 2019 (COVID-19) who are receiving systemic corticosteroids and require supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). This interleukin-6 (IL-6) receptor antagonist is administered IV every 4 weeks for its new GCA indication in combination with a tapering course of glucocorticoids. It is given as a one-time IV dose for its new COVID-19 indication, with an additional dose ≥ 8 hours after the first dose, if needed. Tofidence™ also carries indications for rheumatoid arthritis in select adults and polyarticular or systemic juvenile idiopathic arthritis in patients ≥ 2 years of age.

07/24/2024 Brineura® (cerliponase alfa)

The FDA has expanded the indication of Brineura® for slowing the loss of ambulation in patients with neuronal ceroid lipofuscinosis type 2 (CLN2 disease), also known as tripeptidyl peptidase 1 (TPP1) deficiency, to include all pediatric patients from birth, regardless of whether they are symptomatic or presymptomatic. This hydrolytic lysosomal N-terminal tripeptidyl peptidase from Biomarin was previously approved for use in symptomatic patients ≥ 3 years of age with late infantile CLN2 disease. Brineura® is administered by an HCP via intraventricular infusion once every other week. Notably, dosing is not recommended in patients < 37 weeks post-menstrual age (gestational age at birth plus post-natal age), nor in patients weighing < 2.5 kg.

07/24/2024 Livmarli® (maralixibat)

Mirum’s ileal bile acid transporter (IBAT) inhibitor, Livmarli®, has been granted approval by the FDA to expand its indication for the treatment of cholestatic pruritus in patients with progressive familial intrahepatic cholestasis (PFIC) to include patients ≥ 12 months of age. Livmarli® was previously approved for this indication in patients ≥ 5 years of age. A new higher concentration 19 mg/mL oral solution has also been approved for use in the treatment of PFIC; this oral solution is administered twice daily with dosing based on body weight. An initial titration schedule is included in the labeling. Livmarli® is also indicated for the treatment of cholestatic pruritus in patients ≥ 3 months of age with Alagille syndrome (ALGS); the previously approved 9.5 mg/mL oral solution should be used for its ALGS indication. The AWP for a 30 mL bottle of the new 19 mg/mL strength is $128,160.

07/26/2024 Palforzia® (peanut [Arachis hypogaea] allergen powder-dnfp)

The FDA has expanded approval of Palforzia® to include pediatric patients aged 1 to 3 years for mitigation of allergic reactions, including anaphylaxis, that may occur from accidental exposure to peanut in patients with a confirmed peanut allergy. This oral immunotherapy from Stallergenes Greer was previously approved for patients between the ages of 4 and 17 years only. Palforzia® is available as an oral capsule and sachet, and the initial dose escalation and first dose of each new up-dosing level must be administered by an HCP. For maintenance dosing, therapy is administered by mouth once daily. Palforzia® is to be used in combination with a peanut-avoidant diet.

07/30/2024 Darzalex Faspro® (daratumumab and hyaluronidase-fihj)

The FDA has approved a new indication for Janssen’s Darzalex Faspro®. This product includes the CD38-directed cytolytic antibody, daratumumab, and the endoglycosidase, hyaluronidase, and it has been approved for use in combination with bortezomib, lenalidomide, and dexamethasone for induction and consolidation in adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). This application was granted Priority Review by the FDA. Darzalex Faspro® is administered SC, and its labeling includes a dosing schedule for both the induction and consolidation treatment phases. This drug carries several other indications for use in adults with multiple myeloma and is also indicated in adults with light chain amyloidosis.

07/31/2024 Fibryga® (fibrinogen [human])

Octapharma’s human fibrinogen concentrate Fibryga® has been granted approval for an expanded indication for fibrinogen supplementation in bleeding patients with acquired fibrinogen deficiency. Fibryga® is administered IV as a single dose for this indication, with additional doses given as needed based on plasma fibrinogen levels or thromboelastometry FIBTEM A10 (or equivalent). This product is also indicated for the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia.

08/01/2024 Jemperli (dostarlimab-gxly)

The FDA has expanded approval of GlaxoSmithKline’s Jemperli in combination with carboplatin and paclitaxel, followed by Jemperli as a single agent, to include all adults with primary advanced or recurrent endometrial cancer (EC). Previously, this programmed death receptor-1 (PD-1)-blocking antibody was only approved for this indication in patients with mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) tumors. This application was granted Priority Review by the FDA. When used for its EC indication, Jemperli is administered IV every 3 weeks for 6 cycles in combination with carboplatin and paclitaxel, followed by IV administration every 6 weeks as monotherapy until disease progression, unacceptable toxicity, or up to 3 years. Notably, this product is also approved as a single agent for treatment of select adults with dMMR recurrent or advanced solid tumors and as a single agent for treatment of select adults with dMMR recurrent or advanced EC.

08/07/2024 Fabhalta® (iptacopan)

Fabhalta® has received Accelerated Approval by the FDA for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, generally a urine protein-to-creatinine ratio (UPCR) ≥ 1.5 g/g. Because approval for this new indication was based on a decrease in proteinuria, it has not been established whether Fabhalta® slows kidney function decline in patients with IgAN, and continued approval may require demonstration of benefit in a confirmatory clinical trial(s). This complement factor B inhibitor from Novartis is dosed orally twice daily and also carries an indication for the treatment of adults with paroxysmal nocturnal hemoglobinuria (PNH).

08/15/2024 Imfinzi® (durvalumab)

The FDA has approved a new indication for AstraZeneca’s Imfinzi®. This programmed death-ligand 1 (PD-L1) blocking antibody has been approved for use with platinum-containing chemotherapy as neoadjuvant treatment, followed by use as a single agent as adjuvant treatment after surgery, for adults with resectable (tumors ≥ 4 cm and/or node positive) NSCLC and no known EGFR mutations or anaplastic lymphoma kinase (ALK) rearrangements. Imfinzi® also has existing indications for use in select adults with unresectable stage III NSCLC and metastatic NSCLC, and it also carries indications for select patients with other types of cancer, including small cell lung cancer, biliary tract cancer, hepatocellular carcinoma, and endometrial cancer. This drug is administered as an IV infusion with dosage and duration dependent on the patient’s body weight and indication for use.

08/15/2024 Nexobrid® (anacaulase-bcdb)

Vericel’s Nexobrid® has received approval from the FDA to expand its use for eschar removal in patients with deep partial thickness and/or full thickness thermal burns to include pediatric patients. This biologic proteolytic enzyme topical gel was previously only approved for use in adults. Nexobrid® must be applied by an HCP, and it can be used on areas ≤ 15% body surface area (BSA) for pediatric patients ≥ 6 years of age or areas ≤ 10% BSA for patients < 6 years of age. Product should be removed after 4 hours, and second application is not recommended.

08/19/2024 Rybrevant® (amivantamab-vmjw)

Rybrevant® has been approved under Priority Review by the FDA for use in combination with lazertinib (Lazcluze™) for the first-line treatment of adults with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test. When used for this new indication, this bispecific EGFR-directed and mesenchymal-epithelial transition factor (MET) receptor-directed antibody from Janssen is administered as an IV injection weekly for the first five weeks, then every two weeks starting on week 7 and onwards. The recommended dosage is determined based on body weight, and treatment should be continued until disease progression or unacceptable toxicity. Rybrevant® also carries indications for the first-line treatment of select adults with NSCLC with EGFR exon 20 insertion mutations in combination with carboplatin and pemetrexed, and for the treatment of select adults with NSCLC with EGFR exon 20 insertion mutations as a single agent after disease progression on or after platinum-based chemotherapy.