2seventy bio, Incorporated’s (NASDAQ: TSVT) stock value has increased significantly by 22.03% to $4.88 per share. Recent advancements in therapeutic intervention regulatory approval are mostly to blame for this growth. Today, Bristol Myers Squibb and 2seventy Bio (TSVT) jointly announced that the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted in favor (8-3).
Abecma (idecabtagene vicleucel) has demonstrated a favorable benefit-to-risk ratio for patients with triple-class exposed relapsed or refractory multiple myeloma, according to the ODAC’s decision. This is based on data from the pivotal Phase 3 KarMMa-3 trial, which included the important secondary endpoint of overall survival.
The FDA will consider the ODAC’s suggestion while reviewing the supplementary Biologics License Application (sBLA) for Abecma for this particular patient group. But the FDA hasn’t announced a new target action date for the sBLA review yet.
The positive outcome of the ODAC session underscores the advantageous benefit/risk profile of Abecma. In light of the KarMMa-3 study results, the company maintains confidence in the substantial clinical advantages offered by Abecma for patients with triple-class exposed relapsed or refractory multiple myeloma, a condition currently devoid of a clearly effective standard of care in earlier stages of therapy.
The favorable and supportive outcome of the ODAC meeting marks another stride forward for TSVT in broadening the scope of benefits provided by Abecma to myeloma patients at earlier junctures in their treatment journey.
The affirmative vote from the ODAC ensued subsequent to deliberations on interim overall survival data from the KarMMa-3 study, presented at the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition held in December 2023.
Given the escalating incidence of triple-class exposure in the multiple myeloma treatment landscape, the availability of novel treatment modalities with potential long-term efficacy enhancements at the earliest feasible stages is imperative.
The ODAC’s decision acknowledges this unmet need and advances ide-cel as a novel therapeutic option with demonstrable clinically significant benefits for patients grappling with triple-class exposed relapsed or refractory multiple myeloma.
