- Bristol Myers Squib and partner Bluebird bio have resubmitted an approval application to the Food and Drug Administration for ide-cel, a cell therapy the two companies have been developing for the blood cancer multiple myeloma.
- The FDA surprisingly refused to review the companies' initial application in May, a decision they said was due to a request for details on manufacturing processes. Bristol Myers and Bluebird claim the new submission addresses the agency's ask, but that won't be certain until the FDA accepts the filing and begins a review.
- Timing matters greatly for Bristol Myers and Bluebird. Ide-cel must be approved by March 31 for former Celgene shareholders to get a conditional payment promised in that company's acquisition by Bristol Myers, while the FDA's refusal gave competitor Johnson & Johnson a chance to gain ground with its rival cell therapy.
The filing comes at the eleventh hour for Bristol Myers. When the FDA turned back their initial application in May, the drugmaker promised to resubmit approval papers by the end of July.
By meeting that goal, Bristol still has a chance to hit two key deadlines tied to its $74 billion buyout of Celgene last year. The deadlines hinged on the approval of two experimental cell therapies that Celgene previously acquired rights to through separate deals. Approval of both would trigger an additional $9 per Celgene share payment from Bristol Myers.
The first of those deadlines, for the lymphoma treatment liso-cel, is Dec. 31. The agency twice pushed back a review of liso-cel, but said it would decide by Nov. 16 whether to grant an approval.
Bristol Myers has a bit longer to win clearance for ide-cel — the deadline is March 31 — but delays have cost it some breathing room.
The FDA can take up to 60 days to decide whether an application is acceptable enough to begin a review, which would then start a six- or 10-month clock depending on whether its done on a priority basis or not.
Bristol Myers was previously granted a Breakthrough Therapy designation by the FDA for ide-cel, signaling the FDA's close attention to the treatment.
The FDA's familiarity with the ide-cel application could speed up the process. In a research note, Mizuho Securities analyst Salim Syed wrote the review could start sooner than 60 days given that Bristol Myers only added new manufacturing details, suggesting that the application "otherwise has not materially changed."
Bristol and Bluebird are "committed to working with FDA to progress both applications and achieve the remaining regulatory milestones," they said in a statement, referring to the payments tied to approvals for ide-cel and liso-cel under the Celgene deal.
Even so, the two companies could potentially face more competition than they once did.
If approved before March, ide-cel would be the first such cell treatment to be cleared for multiple myeloma, a deadly cancer of the bone marrow. But a rival therapy developed by Legend Biotech, and later licensed by Johnson & Johnson, has advanced quickly.
Now called JNJ-4528, the treatment produced promising results in December and again in May. J&J's head of oncology clinical development, Craig Tendler, said in a recent interview the company expects to ask for U.S. approval later this year. An application in Europe is expected later this year as well, Legend has said in regulatory filings.
European regulators began reviewing ide-cel on May 20.