After regulatory delays and manufacturing issues caused Bristol Myers Squibb investors to miss out on the benefit of the Celgene quota right, the carefully observed smooth-looking CAR-T drug finally got a nod from the FDA.
On Friday, the agency approved 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 receiving these treatments.
Like other CAR-T drugs, Breyanzi doses are individually adjusted. They are created using the patient’s own T cells, which are extracted, genetically modified and then infused back into patients to help the body destroy lymphoma cells.
ABOUT: Bristol Myers’ head of hematology, Ahmed, walked out the door amid CAR-T’s missteps
In a study of over 250 patients, 54% of patients receiving CAR-T therapy achieved complete remission. The drug label bears a warning in the box for cytokine release syndrome, which can be severe. Because of the safety risks, the FDA requires centers that administer the drug to have a certificate stating that staff have been trained and are able to recognize side effects.
In a conference call earlier this week, Bristol’s chief marketing officer Chris Boerner said the company was waiting for the opportunity to launch the “imminent” smooth. The company will be very focused to ensure at launch that the sites are activated very quickly, that we will be able to switch patients effectively to therapy, he added.
In the future, the company will seek to send recommendations to the drug and expand the number of sites capable of administering it. In the long run, BMS wants to “capitalize on what we believe is a differentiated product profile to boost brand share,” Boerner said.
ABOUT: Bristol Myers CVR on the drain as an FDA manufacturing inspection issue for CAR-T drugs
But while BMS aims to be quickly launched by Breyanzi, the approval process was anything but. Several delays pushed the FDA’s decision after the initial deadline in mid-August 2020 – and eventually cost investors about $ 6.4 billion in value-added contingent rights resulting from Celgene’s purchase of BMS of 74 billions of dollars.
Nearly $ 715 million of CVRs 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 to 2021. Apart from the approval for the cel, CVRs also required FDA approval for multiple myeloma CAR-T med ide-cel by March 31, 2021 and an FDA sign for Zeposia, a drug for multiple sclerosis. Zeposia obtained FDA approval in March last year, and the idea is set for an FDA decision by March 27.