FDA clears BMS CAR-T cell therapy, Merck MET inhibitor

One of the new treatments available is a CAR-T cell therapy to treat relapsed or refractory large B-cell lymphoma.

The FDA cleared two important cancer treatments in the first week of February, including a CAR-T cell therapy for lymphoma,

Lisocabtagene maraleucel; liso-cel (Breyanzi, Bristol Myers Squibb) is a CD19-directed chimeric antigen receptor (CAR-T) cell therapy to treat adults with relapsed or refractory large B-cell lymphoma (LBCL) after two or more lines of systemic therapy,

Related: FDA clears first cell-based gene therapy for lymphoma

“Today’s approval represents another milestone in the rapidly progressing field of gene therapy by providing an additional treatment option for adults with certain types of cancer affecting the blood, bone marrow, and lymph nodes,” said Peter Marks, M.D., PhD, director of the FDA’s Center for Biologics Evaluation and Research, in a press release. “Gene and cell therapies have evolved from promising concepts to practical cancer treatment regimens.”

Bristol Myers Squibb plans to manufacture Breyanzi for each individual patient, with a 24-day target turnaround time, and inpatient or outpatient administration options, the company said in a press release.

“Breyanzi…will have an important role in clinical practice, offering people living with relapsed or refractory large B-cell lymphoma the chance for sustained response with an individualized treatment experience,” said Samit Hirawat, MD, chief medical officer for the company.

Related: Pharma maker seeks fast approval of lymphoma treatment

The pharma maker plans to launch Breyanzi across an expansive network of treatment centers. Treatment centers will be Risk Evaluation and Mitigation Strategy (REMS) certified to support the appropriate use of the drug.

The agency also approved tepotinib (Tepmetko, Merck) to treat adults with metastatic non-small cell lung cancer harboring mesenchymalepithelial transition (MET) exon 14 skipping alterations.

The indication was cleared under accelerated approval based on overall response rate and duration of response, FDA said in its Clinical Pharmacology Corner e-newsletter.

The recommended dosage of Tepmetko is 450 mg orally once daily with food until disease progression or unacceptable toxicity.

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