FDA Target Dates for Potential Cancer Drug Approvals in Early 2022

The year 2021 was full of Food and Drug Administration (FDA) approvals that may help patients with cancer live longer and better lives. But the agency did not only approve drugs; they also granted priority reviews and set decision dates for up-and-coming treatments that may continue to reform the world of cancer.

When the FDA decides to review a certain treatment for a possible approval, they set a Prescription Drug User Feed Act (PDUFA) decision date, which states that the agency may approve the drug or not within a certain timeline. But when a drug has particularly promising results in a clinical trial, the FDA may grant it a priority review, which means it tends to speed up the review of the therapy.

Of note, the FDA may not make a decision to approve the drug by its PDUFA date and request more information from the manufacturer before a decision is made. The FDA may make a decision ahead of the PDUFA date, too.

CURE® looked at incoming PDUFA dates and created a roundup of what may be expected within the first fiscal quarter (January through March) of 2022.

January: Libtayo for Advanced Cervical Cancer

The FDA granted a priority review to a supplemental biologics license application (sBLA) — which is basically a priority review for a drug that has already been approved in another indication — for Libtayo (cemiplimab-rwlc) to treat patients with recurrent or metastatic cervical cancer whose disease progressed after platinum-based chemotherapy.

The sBLA is based off findings from the phase 3 EMPOWER-Cervical 1/GOG-3016/ENGOT-cx9 trial, which showed that Libtayo led to a meaningful improvement in overall survival compared with chemotherapy.

The PDUFA decision date is set for Jan. 30, 2022.

February: Cilta-cel for Relapsed/Refractory Multiple Myeloma

The FDA originally set a PDUFA decision date for cilta-cel (ciltacabtagene autoleucel) in myeloma in Nov. 2021, but then granted an extension to allow for more data to be analyzed from the phase 1/2 CARTITUDE-1 clinical trial, examining cilta-cel in adults with relapsed/refractory myeloma.

In December, results of CARTITUDE-1 were presented at the American Society of Hematology Annual Meeting, showing that 97.9% of patients had their disease shrink as a result of the CAR-T cell therapy cilta-cel, while 82.5% experienced a stringent complete response. Stringent complete response indicates an even deeper response than a standard complete response.

The PDUFA decision date is now set for Feb. 28, 2022.

March: Relatlimab Plus Opdivo for Metastatic Melanoma

According to findings from the phase 2/3 RELATIVITY-047 clinical trial, the combination of relatlimab (a novel agent) plus Opdivo (nivolumab; an immunotherapy drug) led to twice as long progression-free survival in patients with untreated advanced melanoma compared with those given Opdivo alone. On average, it took patients on the two-drug regimen 10.1 months to experience progression, while patients on Opdivo only had an average time to progression of 4.6 months.

These promising findings from RELATIVITY-047 led the FDA to grant the drug combination a priority review.

The PDUFA decision date is set for March 9, 2022.

Quarter 1, 2022: Lynparza for BRCA-Positive, High-Risk, Early Breast Cancer

Lynparza (olaparib) was granted a priority review for the adjuvant (after surgery or other main form of treatment)treatment of patients with BRCA-positive/HER2-negative, high-risk early breast cancer based on findings from the phase 3 OlympiA trial, which reduced the risk of invasive breast cancer recurrence and second cancers or death by 42% compared with placebo.

Additionally, research also showed that Lynparza does not significantly impact patients’ quality of life, as side effects from PARP inhibitor — such as fatigue, nausea and vomiting — tended to be easily managed.

The FDA plans to make its decision on the drug’s approval by the end of the first quarter of 2022.

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