- The Food and Drug Administration has extended its review of Bristol Myers Squibb's cancer cell therapy liso-cel by three months after receiving new information it requested from the company.
- The agency's timeline is being closely watched by investors because of a provision in Bristol Myers' takeover of Celgene that promised an extra $9 per share to Celgene investors if three therapies, including liso-cel, were approved by certain dates.
- The FDA now plans to decide on liso-cel by Nov. 16, Bristol Myers said in a May 6 statement. Per Bristol Myers' deal terms with Celgene, the drug must be approved by Dec. 31 for holders of the contingent value rights to have a chance at the payout.
Any delay is cause for worry for CVR holders as the deadline gets closer for liso-cel approval, and Bristol Myers isn't giving details about the new information requested by the FDA. Still, requests that trigger longer review times aren't unusual, Mizuho Securities analyst Salim Syed wrote in a note to investors.
"My general thought here is the CVR is still intact," Syed wrote.
Syed offered a list of five products that had review delays and still won approval. In those cases, the FDA sought items such as "additional analytical information" and details on chemistry and manufacturing, he said.
Such requests are also generally intended to "address outstanding deficiencies in the application and lead to approval in the current review cycle," Syed said, citing FDA guidelines.
Yet this isn't the first delay for liso-cel, which is under review to treat relapsed or refractory large B-cell lymphoma after prior treatments.
Juno Therapeutics originally developed the treatment and executives at the company at one point were communicating hopes for an FDA approval as early as 2018. Celgene then bought Juno and predicted U.S. clearance in 2019, before revising that guidance to mid-2020.
Bristol Myers filed for approval of liso-cel in December 2019 and in February announced the therapy won a Priority Review from the FDA, with a target action date of Aug. 17.
The FDA has already approved one of the three products involved in the Celgene CVR, a multiple sclerosis treatment called ozanimod, which is sold as Zeposia. The deadline under the CVR for clearance of the third therapy, the multiple myeloma treatment ide-cel, is March 31, 2021.
CVR investors are also carefully watching the effects of COVID-19 on FDA inspections required before approvals. In March, the agency announced plans to scale back domestic inspections to protect both its own staff and industry employees from the novel coronavirus, raising concerns of further delays.