On September 24, 2021 Secura Bio reported that The FDA initially targeted immunotherapies in its industry-wide review of accelerated drug approvals in oncology that failed to deliver in confirmatory trials. But the agency isn’t stopping there (Press release, Secura Bio, SEP 24, 2021, View Source [SID1234590541]).
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The FDA is gathering an oncologic drugs advisory committee meeting on Dec. 2 to review whether two drugs should keep their conditional approvals, the agency said (PDF) Friday. The products are Secura Bio’s Farydak for previously treated multiple myeloma, and Aurobindo Pharma’s Marqibo indication for Philadelphia chromosome-negative acute lymphoblastic leukemia (ALL) following two or more lines of treatments.
In the spring, the FDA’s Oncology Center of Excellence launched an industry-wide review of accelerated approvals that haven’t shown clinical benefits in confirmatory trials. The campaign cost PD-1/L1 inhibitors from Merck, Bristol Myers Squibb, Roche and AstraZeneca several U.S. indications, including small cell lung cancer, stomach cancer, bladder cancer, liver cancer and triple-negative breast cancer.
RELATED: Subcutaneous Velcade more tolerable in multiple myeloma trial
Now Secura and Farydak will have to prepare for the same scrutiny. Secura bought worldwide rights to Farydak from Novartis in 2019. The drug’s original FDA nod in 2015 was a hard-fought one, given that the FDA’s external experts voted against its approval due to concerns about side effects. Farydak is indicated for use with Takeda’s Velcade and the steroid dexamethasone.
The latest data on Fradyak, released earlier this year, came from a phase 2 trial dubbed Panorama 3. The trial tested Fradyak with a subcutaneous version of Velcade, rather than its original intravenous formulation. It showed that Fradyak, at its approved dosing strength, produced a similar response rate with the new regimen as that shown in the original Panorama 1 trial, but that it had a longer duration of response. Patients taking the combination with subcutaneous Velcade reported fewer side effects, such as severe diarrhea, than what was observed in the earlier trial."
In a statement to Fierce Pharma, Secura chief medical officer David Cohan, M.D., said the company remains "committed to working with the FDA on fulfilling all post-marketing requirements for Farydak in a timely manner."
As for Marqibo, that drug got its FDA go-ahead in 2012 and has since changed hands twice, first from Talon Therapeutics to Spectrum Pharmaceuticals in 2013 and then to Aurobindo in 2019. The drug earned its third-line ALL approval after a single-arm phase 2 study recorded a 15.4% complete response rate.
The phase 3 Hallmarq trial in patients over 60 with newly diagnosed ALL was supposed to serve as Marqibo’s confirmatory trial. The plan was to enroll 348 patients and compare Marqibo, a targeted version of chemotherapy vincristine, with standard vincristine. But Spectrum terminated the study in 2015, after recruiting just 26 participants over three years, according to clinicaltrials.gov.
RELATED: Bristol Myers pulls an Istodax lymphoma use 10 years after FDA accelerated approval
The upcoming advisory committee meeting "will have a general discussion focused on next steps for each product including whether the indications should remain on the market while additional trial(s) are conducted," the FDA said in a notice Friday.
Some pharma companies seem to be realizing that the FDA is moving its house-cleaning beyond immuno-oncology agents. And they’re getting ahead of any negative decisions. Bristol Myers in August said it’s withdrawing Istodax’s indication as a monotherapy for previously treated peripheral T-cell lymphoma after a recent confirmatory phase 3 trial flop in newly diagnosed patients.