Bristol Myers, bluebird Submit BLA for Myeloma Drug to FDA
Bristol-Myers Squibb Company BMY along with partner bluebird bio, Inc. BLUE announced that both have submitted a biologics license application (BLA) to the FDA for their lead investigational BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy candidate, idecabtagene vicleucel.
The companies are seeking approval of the candidate for the treatment of adult patients with multiple myeloma (MM), having received minimum three prior therapies including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody.
The BLA was based on data from the pivotal phase II KarMMa study, which evaluated the efficacy and safety of idecabtagene vicleucel in heavily pre-treated patients with relapsed/refractory MM.
In December 2019, both companies announced top-line results from the above study. The evaluation met its primary endpoint of overall response rate and key secondary endpoint of complete response rate in the given patient population.
Overall, the safety results were similar to those observed in the phase I CRB-401 study, which investigated the preliminary safety and efficacy of idecabtagene vicleucel. The companies plan to present comprehensive results from the KarMMa study at a future medical conference.
Shares of Bristol-Myers were up 2.5% following the above-mentioned announcement on Tuesday. However, the stock has declined 13.1% so far this year compared with the industry’s decrease of 11%.
Notably, idecabtagene vicleucel is being developed as part of a co-development, co-promotion and profit sharing agreement between Bristol-Myers and bluebird. The candidate was added to the company’s portfolio post the acquisition of Celgene Corporation last November.
Idecabtagene vicleucel is also being evaluated in other clinical studies to address patients with MM in earlier-line settings including the newly diagnosed ones.
We note that in November 2017, idecabtagene vicleucel was granted a Breakthrough Therapy designation by the FDA and PRIority Medicines (PRIME) eligibility by the European Medicines Agency for the treatment of relapsed/refractory MM.
Zacks Rank & Other Stocks to Consider
Bristol-Myers currently carries a Zacks Rank #2 (Buy). Other top-ranked stocks in the large cap pharma sector include Innoviva, Inc. INVA and Eli Lilly and Company LLY, both sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Innoviva’s earnings estimates have been revised 16.4% upward for 2020 over the past 60 days.
Eli Lilly’s earnings estimates have moved 0.1% north for 2020 over the past 60 days. The stock has rallied 5.6% year to date.
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