PRINCETON, N.J. & CAMBRIDGE, Mass. - Bristol Myers Squibb (NYSE: NYSE:BMY) and 2seventy bio, Inc. (Nasdaq: TSVT) recently announced that the U.S. Food and Drug Administration (FDA) is scheduled to review additional data for Abecma® (idecabtagene vicleucel) on March 15, 2024. The review will focus on the supplemental Biologics License Application (sBLA) for Abecma in the treatment of triple-class exposed relapsed or refractory multiple myeloma.
The Oncologic Drugs Advisory Committee (ODAC) will examine the overall survival data from the KarMMa-3 study, which was presented at the American Society of Hematology Annual Meeting in December 2023. The study's findings are pivotal to the sBLA.
Abecma has already made strides in Japan, where it is approved for patients with relapsed or refractory multiple myeloma after at least two prior therapies. This approval marked it as the first CAR T cell therapy for earlier lines of therapy in this patient population. It also received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for a similar indication.
Currently, regulatory applications in the European Union and with Swissmedic are under review for Abecma for the treatment of patients with triple-class exposed relapsed and refractory multiple myeloma after at least two prior therapies.
Abecma, a CAR T cell therapy, targets the B-cell maturation antigen (BCMA) present on multiple myeloma cells, leading to the destruction of these cancer cells. In the United States, it is already approved for adult patients with relapsed or refractory multiple myeloma who have undergone four or more prior lines of therapy.
The collaboration between Bristol Myers Squibb and 2seventy bio includes the co-development and commercialization of Abecma in the U.S. and a broad clinical development program with ongoing and planned clinical studies.
The FDA's upcoming review is based on a press release statement by the companies involved. The review's outcome could potentially expand the treatment options for patients with multiple myeloma, offering a new avenue of care for those who have been exposed to multiple classes of prior therapies.
InvestingPro Insights
As Bristol Myers Squibb (NYSE: BMY) awaits the FDA's decision on Abecma, investors might consider the company's current financial health and market standing. With a robust market capitalization of $99.11B and a P/E ratio that has adjusted to a more attractive 10.47, BMY stands as a solid player in the pharmaceuticals industry. Notably, the company is trading at a low P/E ratio relative to near-term earnings growth, which is reflected in its PEG ratio of just 0.4, suggesting that the stock could be undervalued based on its earnings growth potential.
InvestingPro Tips highlight that Bristol Myers Squibb has been actively buying back shares, signaling management's confidence in the company's value. Additionally, the company has a high shareholder yield and a strong free cash flow yield, which could be appealing to investors seeking companies with solid financial returns. With 54 consecutive years of maintained dividend payments, currently yielding 4.93%, BMY demonstrates a commitment to returning value to shareholders.
For those considering an investment, it's worth noting that BMY is trading near its 52-week low, potentially offering a buying opportunity. Analysts predict profitability for the company this year, backed by a profitable performance over the last twelve months. With these insights, and 10 more detailed InvestingPro Tips available for subscribers, interested investors can make more informed decisions.
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