FDA Schedules ODAC Meetings to Review Pending Drug Applications

The FDA has scheduled 3 sessions for the Oncologic Drugs Advisory Committee (ODAC) to review updates on the new drug application (NDA) for poziotinib tablets and data for the continued approval of indications for melphalan flufenamide (Pepaxto) and duvelisib (Copiktra).¹

On September 22, 2022, the committee will review data from the phase 2 ZENITH20 trial (NCT03318939) supporting the NDA for approval of poziotinib for patients with previously treated locally advanced or metastatic non–small cell lung cancer with HER2 exon 20 insertion mutations. The agency granted the NDA a fast-track designation, and the anticipated approval date is November 24, 2022.² Among 90 patients, the objective response rate was 27.8% (95% CI, 18.9%-38.2%), with 25 patients having a partial response. The median duration of response was 5.1 months, and the disease-control rate was 70%.

During the second session, also scheduled for September 22, ODAC will discuss the benefit-risk ratio and continued approval of melphalan flufenamide for patients with relapsed or refractory multiple myeloma who have received at least 4 prior lines of therapy and whose disease is refractory to at least 1 proteasome inhibitor, 1 immunomodulatory agent, and 1 CD38-directed monoclonal antibody. The agent received accelerated approval in 20213; however, data from the phase 3 OCEAN trial (NCT03151811) did not meet the primary end point of improved overall survival vs pomalidomide.⁴

Lastly, on September 23, ODAC will review long-term data from the phase 3 DUO trial (NCT02004522), submitted as part of the postmarketing requirement for the continued approval of duvelisib for patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least 2 prior therapies. The FDA had approved the agent in 2018 based on earlier data from DUO.⁵ In June 2022 the agency issued a drug safety communication warning of an increased incidence of adverse effects, including infections, diarrhea, inflammation of the intestines and lungs, skin reactions, and high liver enzyme levels in the blood.⁶

The purpose of these meetings is to provide guidance. Final decisions on these agents will ultimately be made by the FDA.

The meetings will be available via live webcast and archived after the sessions.

References

1. September 22-23, 2022: meeting of the Oncologic Drugs Advisory Committee meeting announcement. FDA. Updated July 22, 2022. Accessed August 4, 2022. bit.ly/3OOg6Ju
2. Spectrum Pharmaceuticals announces acceptance of new drug application filing for poziotinib. News release. Spectrum Pharmaceuticals; February 11, 2022. Accessed August 4, 2022. bit.ly/3gGReox
3. FDA grants accelerated approval to melphalan flufenamide for relapsed or refractory multiple myeloma. FDA. Updated March 1, 2022. Accessed August 4, 2022. bit.ly/3OZIxEz
4. Oncopeptides withdraws Pepaxto in US, scale down organization and focus on R&D. News release. Oncopeptides AB. October 22, 2021. Accessed August 4, 2022. prn.to/3cUFH6c
5. duvelisib (Copiktra, Verastem, Inc.) for adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). FDA. September 24, 2018. Accessed August 4, 2022. bit.ly/3vH541X
6. Copiktra (duvelisib): drug safety communication - FDA warns about possible increased risk of death and serious side effects. FDA. June 30, 2022. Accessed August 4, 2022. bit.ly/3zu7GS4