After regulatory delays and manufacturing problems caused Bristol Myers Squibb investors to lose Celgene’s lucrative contingent value, the closely-watched, smooth-cell CAR-T drug finally got a gesture of the FDA.
On Friday, the agency approved the drug, which will be called Breyanzi, to treat 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, Breyanzi doses are individually tailored. They are created using the patient’s own T cells, which are extracted, genetically modified and re-infused into patients to help the body kill lymphoma cells.
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In one trial of more than 250 patients, 54% of patients receiving CAR-T therapy achieved complete remission. The drug’s label contains a box warning about cytokine release syndrome, which can be serious. Because of safety risks, the FDA requires that centers administering the drug have a certification stating that staff have been trained and able to recognize side effects.
In a conference call earlier this week, Bristol chief marketing officer Chris Boerner said the company looks forward to the opportunity to launch smooth-sky “imminently”. The company “will be very focused on ensuring at launch that the sites are activated very quickly, that we can get patients to switch to therapy efficiently,” he added.
Looking to the future, the company will try to boost referrals to medicine and expand the number of sites capable of administering it. In the long run, BMS wants to “take advantage of what we believe is a differentiated product profile in order to generate brand share,” Boerner said.
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But while BMS aims to quickly deploy Breyanzi, the process for approving it was anything but. Several delays pushed the FDA’s decision beyond the original mid-August 2020 deadline and ultimately cost investors about $ 6.4 billion in value contingent rights that came out of Celgene’s purchase of BMS, $ 74 billion.
Nearly $ 715 million of CVR worth $ 9 per share were outstanding at the end of the year, and since BMS did not meet all of the CVR requirements, they had no value when the calendar year passed in 2021. Apart from liso-cell approval, CVRs also require FDA approval for CAR-T cell ideology of multiple myeloma before March 31, 2021 and an FDA gesture for Zeposia, a drug for l ‘multiple sclerosis. Zeposia obtained its FDA approval last March and ide-cel is scheduled for an FDA decision on March 27.