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J&J (JNJ) Begins Rolling BLA Filing of Multiple Myeloma Drug

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Johnson & Johnson’s (JNJ - Free Report) announced that it has initiated the rolling submission of its biologics license application (BLA) to the FDA for its BCMA CAR-T therapy, ciltacabtagene autoleucel (cilta-cel). Cilta-cel has been developed for the treatment of adult patients with relapsed/refractory multiple myeloma (“MM”).

A rolling review of the BLA for the BCMA CAR-T candidate has been agreed upon by the FDA. In said review, completed portions of the application will be submitted and reviewed at regular intervals.

The BLA is based on data from the ongoing phaseIb/II CARTITUDE-1 study which is evaluating the safety and efficacy of cilta-cel for the given indication. The primary goal of the phase Ib portion of the study was to confirm the dose of cilta-cel and characterize the safety in the given patient population. Based on these safety profiles, the phase II portion is investigating the efficacy of cilta-cel at the recommended dose with overall response as the primary endpoint.

Shares of J&J have rallied 4.9% so far this year compared to the industry’s increase of 3%.

price chart for JNJ


The study is being conducted as a part of Janssen Biotech’s ongoing collaboration with Legend Biotech. In late 2017, the companies entered into an exclusive worldwide license and collaboration agreement to develop/commercialize cilta-cel.

Notably, the FDA granted an orphan drug designation and a breakthrough therapy designation to cilta-cel for treating relapsed/refractory MM. The European Commission has also bestowed PRIority MEdicines (PRiME) designation and orphan drug tag to cilta-cel for the given indication.

Per the press release, in the United States an estimated 32,270 people will be diagnosed with MM in 2020, out of which around 12,830 people will die from the disease. Hence, if successfully developed, and upon potential approval, cilta-cel can be a highly active, dual-binding BCMA CAR-T therapy to serve patients with relapsed/refractory MM.

We note that cilta-cel, upon potential approval, is likely face competition from bluebird bio (BLUE - Free Report) and Bristol Myers’ (BMY - Free Report) investigational BCMA-directed CAR-T therapy, idecabtagenevicleucel (ide-cel), which has also been developed for relapsed/refractory MM. The candidate is currently under priority review in the United States and the FDA has set an action date of Mar 27, 2021.

Zacks Rank & Key Pick

J&J currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the drug/biotech sector is Ironwood Pharmaceuticals, Inc. (IRWD - Free Report) , which has a Zack Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Ironwood’s earnings estimates have moved 25.9% and 23.6% north for 2020 and 2021, respectively, over the past 60 days.

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