After regulatory delays and manufacturing issues caused investors in Bristol Myers Squibb to miss out on the lucrative Celgene contingent right, the closely watched CAR-T drug liso cel has finally gotten an FDA nod.
On Friday, the agency approved the drug, which will be called Breyanzi, for the treatment of patients with certain types of large B-cell lymphoma who have not responded to two other systemic treatments or who have relapsed after receiving those treatments.
Like other CAR-T drugs, doses of Breyanzi are individually adjusted. They are made using a patient’s own T cells, which are extracted, genetically modified, and then given back to patients to help the body kill lymphoma cells.
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In a study of more than 250 patients, 54% of patients who received CAR-T therapy achieved complete remission. The drug’s label has a boxed warning about cytokine release syndrome, which can be serious. Due to safety concerns, the FDA requires centers that administer the drug to have certification that staff are trained and able to recognize side effects.
In a conference call earlier this week, Chris Boerner, Bristol’s Chief Commercialization Officer, said the company expects the opportunity to launch liso-cell “imminent”. The company will be “very focused at launch to ensure sites are up and running very quickly, that we can move patients efficiently into therapy,” he added.
Looking ahead, the company will strive to drive referrals to the drug and expand the number of sites it can administer. In the long run, BMS wants to “leverage what we believe is a differentiated product profile to increase brand share,” said Boerner.
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But while BMS is committed to rolling out Breyanzi quickly, the process of getting it approved was anything but. Multiple delays pushed the FDA’s decision past its original mid-August 2020 deadline – ultimately investing approximately $ 6.4 billion in contingent value rights stemming from Celgene’s $ 74 billion purchase by BMS.
At the end of the year, nearly 715 million CVRs worth $ 9 per share were outstanding, and since BMS did not meet all CVR requirements, they were worthless when the calendar year turned to 2021. Aside from a liso-cel approval, The CVRs also required FDA approval for multiple myeloma CAR-T medide cell by March 31, 2021, and an FDA nod for Zeposia, an anti-multiple sclerosis drug. Zeposia received FDA approval last March, and ide cell will receive a decision from the FDA on March 27.