FDA Decisions Loom for Major Pharmaceutical Companies in Late July

In a flurry of regulatory activity, the U.S. Food and Drug Administration (FDA) is set to make several high-stakes decisions on drug applications from leading pharmaceutical companies by the end of July. These verdicts span a range of therapeutic areas, including oncology, rare diseases, and hormone deficiencies, potentially reshaping treatment landscapes for patients and impacting company fortunes.

Oncology Therapies Take Center Stage

Roche is seeking to expand the use of its T cell engager Columvi (glofitamab) in diffuse large B cell lymphoma (DLBCL). The company has filed a supplemental Biologics License Application (sBLA) for Columvi in combination with chemotherapy for patients who have undergone at least one prior line of therapy. The FDA's decision is expected by July 20. Data from the Phase III STARGLO study showed that the Columvi combination reduced the risk of death by 41% compared to a rituximab-based regimen.

Replimune awaits an FDA verdict by July 22 for its oncolytic immunotherapy RP1 in combination with Bristol Myers Squibb's Opdivo (nivolumab) for advanced melanoma. The RP1 construct, based on a modified herpes simplex virus, aims to directly destroy cancer cells while stimulating an immune response. The IGNYTE study demonstrated an overall response rate of 32.9% and a complete response rate of 15%.

GSK is poised for a potential comeback with its antibody-drug conjugate Blenrep (belantamab mafodotin) in relapsed or refractory multiple myeloma, with an FDA decision expected by July 23. After withdrawing Blenrep from the U.S. market in late 2022 due to disappointing trial results, GSK is now armed with positive data from the DREAMM-7 and DREAMM-8 trials, showing significant improvements in progression-free survival.

Rare Diseases and Hormone Therapies in Focus

Sobi is seeking pediatric approval for its thrombopoietin receptor agonist Doptelet (avatrombopag) in children aged one year and older with persistent or chronic immune thrombocytopenia. The FDA's decision is due by July 24, based on data from the AVA-PED-301 trial.

Ascendis Pharma anticipates an FDA verdict by July 27 for its growth hormone Skytrofa (lonapegsomatropin-tcgd) in adult patients with growth hormone deficiency. The application is supported by data from the Phase III foresiGHt study, which demonstrated significant reductions in trunk fat and improvements in lean mass.

Apellis Pharmaceuticals aims to expand the label of its complement inhibitor Empaveli (pegcetacoplan) to cover two rare kidney diseases: C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN). The FDA's decision is expected by July 28, based on results from the Phase III VALIANT study.