After regulatory delays and manufacturing problems caused investors at Bristol Myers Squibb to lose Celgene’s lucrative contingent value, the closely monitored smooth-cel drug CAR-T finally obtained FDA approval.
On Friday, the agency endorsed 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 these treatments.
Like other CAR-T drugs, Breyanzi doses are adjusted individually. They are created using the patient’s own T cells, which are extracted, genetically modified and then infused back into the patients to help the body kill the 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 carries a boxed warning for cytokine release syndrome, which can be severe. Because of the safety risks, the FDA is requiring that centers that administer the drug have a certification indicating that the team has been trained and is able to recognize side effects.
In a conference call earlier this week, Bristol’s chief marketing officer, Chris Boerner, said the company expected the opportunity to launch the flat-cel “soon”. The company “will be very focused on ensuring, at launch, that the sites are activated very quickly, that we can take patients efficiently to therapy,” he added.
Looking to the future, the company will seek to direct references to the drug and expand the number of sites capable of administering it. In the long run, BMS wants to “leverage what we believe to be a differentiated product profile to boost brand participation,” said Boerner.
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But while BMS intends to launch Breyanzi quickly, the approval process was anything but. Multiple delays pushed the FDA decision beyond the original mid-August 2020 deadline – and it finally cost investors about $ 6.4 billion in contingent value rights that came out of BMS’s $ 74 billion Celgene purchase .
Nearly 715 million CVRs worth $ 9 per share were outstanding at the end of the year and, as BMS did not meet all CVR requirements, they were useless when the calendar year passed to 2021. In addition to the approval of the flat -cel, CVRs also required FDA approval for multiple myeloma CAR-T med ide-cel by March 31, 2021, and FDA approval for Zeposia, a multiple sclerosis drug. Zeposia obtained FDA approval last March, and the ide-cel is scheduled for an FDA decision on March 27.