FDA's July Docket: Key Decisions Ahead for Roche, GSK, and More

The U.S. Food and Drug Administration (FDA) is set to make several significant decisions in the latter half of July, with potential approvals spanning various therapeutic areas including lymphoma, multiple myeloma, and rare diseases. These rulings could reshape treatment landscapes and offer new options for patients.

Roche Seeks Expanded Use for Columvi in DLBCL

Roche is aiming to broaden the application of its T cell engager Columvi (glofitamab) for diffuse large B cell lymphoma (DLBCL). The company has submitted a supplemental Biologics License Application (sBLA) to use 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.

Currently approved for DLBCL patients who have received at least two lines of systemic therapies, Columvi's potential expansion is supported by data from the Phase III STARGLO study. Results showed that when combined with gemcitabine and oxaliplatin, Columvi reduced the risk of death by 41% compared to a rituximab-based regimen. The Columvi combination also decreased the risk of death or disease progression by 63%.

If approved, Columvi could become an off-the-shelf, fixed-duration treatment option available soon after diagnosis for DLBCL patients.

GSK's Blenrep Seeks Comeback in Multiple Myeloma

GSK is making another attempt to secure approval for its antibody-drug conjugate Blenrep (belantamab mafodotin) in relapsed or refractory multiple myeloma. The FDA is expected to announce its decision by July 23.

Blenrep was initially approved for this indication in August 2020 under the FDA's accelerated pathway. However, GSK voluntarily withdrew the drug from the U.S. market in November 2022 following disappointing results from the confirmatory Phase III DREAMM-3 trial.

Now, armed with data from the DREAMM-7 and DREAMM-8 trials, GSK is giving Blenrep another chance. Both studies demonstrated significant improvements in progression-free survival for Blenrep-treated patients compared to standard-of-care triplet regimens. A planned interim analysis of DREAMM-7 also indicated potential overall survival benefits.

Emerging Therapies for Rare Diseases and Metabolic Disorders

Several other noteworthy decisions are expected in the coming weeks:

• Replimune's RP1, an oncolytic immunotherapy, is under review for use in combination with Bristol Myers Squibb's Opdivo (nivolumab) to treat advanced melanoma. The FDA's decision is due by July 22.

• Sobi is seeking approval for Doptelet (avatrombopag) in children aged one year and older with persistent or chronic immune thrombocytopenia. The target decision date is July 24.

• Ascendis Pharma's growth hormone Skytrofa (lonapegsomatropin-tcgd) is being considered for use in adult patients with growth hormone deficiency, with a verdict expected by July 27.

• Apellis Pharmaceuticals is looking to expand the label of its complement inhibitor Empaveli (pegcetacoplan) to cover C3 glomerulopathy and primary immune complex membranoproliferative glomerulonephritis. The FDA's decision is due by July 28.

• PTC Therapeutics' sepiapterin for phenylketonuria in adults and children awaits a decision by July 29.

• Regeneron's bispecific T cell engager odronextamab for relapsed or refractory follicular lymphoma is expecting a verdict on July 30.

These upcoming decisions underscore the pharmaceutical industry's continued focus on addressing unmet medical needs across a spectrum of conditions, from rare diseases to more common malignancies.