After the regulatory delays and manufacturing problems investors of Bristol Myers Squibb missed the lucrative Celgene conditional value right, the meticulous CAR-T drug liso-cell finally got an FDA nod.
On Friday, the agency endorsed the drug, called Breyanzi, to treat patients with certain types of large B-cell lymphoma who did not respond to two other systemic treatments or who relapsed after treatment.
Like other CAR-T drugs, Breyanzi doses are adjusted individually. It is made using a patient’s own T cells, which are extracted, genetically modified and then re-administered to patients to help kill the body’s lymphoma cells.
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In a study of more than 250 patients, 54% of the patients who received the CAR-T therapy achieved complete remission. The label of the drug contains a warning for cytokine release syndrome, which can be serious. Due to safety risks, the FDA requires centers that administer the drug to have a certification that indicates that staff are trained and can recognize side effects.
In a conference call earlier this week, Chris Boerner, head of commercialization, said the company expects the opportunity to ‘launch’ liso-cell immediately. The company will ‘focus a lot on ensuring that websites are activated very quickly at launch, so that we can move patients efficiently to therapy,’ he added.
The company will look forward to increasing referrals to the drug and expanding the number of sites it can administer. In the long run, BMS wants to ‘use what we believe is a differentiated product profile to increase trading share,’ Boerner said.
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But while BMS is trying to get Breyanzi executed quickly, the process of getting it approved was anything but. Multiple delays have pushed the FDA’s decision beyond the original mid-August 2020 deadline – eventually costing investors about $ 6.4 billion in contingent liabilities arising from BMS’s $ 74 billion Celgene purchase.
Nearly $ 715 million CVRs worth $ 9 per share were outstanding at the end of the year, and since BMS did not meet all the CVR requirements, it was worthless when the calendar year turned to 2021. Apart from an approval for lyso cell, the CVRs also require an FDA approval for multiple myeloma CAR-T med ide cell on 31 March 2021, and an FDA nod for Zeposia, a drug with multiple sclerosis . Zeposia obtained its FDA approval last March, and ide cell will be decided by the FDA by March 27.