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FDA Sets Review Date for Odronextamab to Treat Blood Cancers
Odronextamab is a bispecific antibody to treat relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma. The target action date is March 31, 2024.
The FDA has granted priority review for Regeneron’s biologics license application (BLA) for odronextamab to treat adult patients with relapsed/refractory follicular lymphoma (FL) or R/R diffuse large B-cell lymphoma (DLBCL). The target action date for the FDA decision is March 31, 2024.
Follicular lymphoma and diffuse large B-cell lymphoma are the two most common subtypes of B-cell non-Hodgkin lymphoma. FL is a slow-growing subtype, and although many patients are responsive to initial treatment, about 20% are expected to relapse within two years. DLBCL is an aggressive subtype, with up to 50% of high-risk patients experiencing progression after first-line treatment.
Odronextamab is an investigational CD20xCD3 bispecific antibody designed to target both CD20 on cancer cells and CD3-expressing T cells.
The BLA was supported by data from a phase 1 and pivotal phase 2 trial (ELM-1 and ELM-2). Results from these studies investigating odronextamab in both FL and DLBCL were presented lst year at the American Society of Hematology Annual Meeting.
In the phase 2 trial, 121 patients with follicular lymphoma were treated with a step-up regimen of odronextamab in the first cycle to help mitigate the risk of cytokine release syndrome before receiving the full dose of 80 mg. odronextamab resulted in a 82% objective response rate (ORR), with 75% achieving a complete response. The median duration of complete response. was 20.5 months. Median progression-free survival was 20 months.
Cytokine release syndrome was the most common adverse event and 68% of the cases were mild. Discontinuations due to an adverse events occurred in 11.5% of patients, and there were three deaths due to pneumonia, progressive multifocal leukoencephalopathy and systemic mycosis.
Additionally, the phase 2 enrolled 130 with diffuse large B-cell lymphoma who had not received prior CAR-T therapy. In these patients, odronextamab resulted in a 49% objective response rate, with 31% achieving a complete response. The median duration of complete response (mDOCR) was 18 months.
Cytokine release syndrome was the most common adverse event, and 64% of cases were mild. Discontinuations due to an adverse event occurred in 10% of patients, and there were five deaths due to pneumonia, COVID-19 and pseudomonal sepsis.
Based on these data from the phase 2 trial, Regeneron has initiated a phase 3 program in earlier lines of therapy.
FDA Approves Xolremdi for Ultra Rare Immune Disorder
April 29th 2024Xolremdi is the first therapy for WHIM syndrome, which can cause recurrent lung infections and papillomavirus-related warts. It’s available in two doses: 400 mg for an annual cost of $496,400 and 300 mg for an annual cost of $372,300.
FDA Approves Pfizer’s Gene Therapy Beqvez for Hemophilia
April 26th 2024Beqvez (fidanacogene elaparvovec) is priced at $3.5 million, which is on parity with Hemgenix, the first one-time therapy to treat adults with hemophilia B. Pfizer’s warranty will refund insurers and continue to provide coverage for patients if they change insurers.
