A Look Back at FDA News from September 2022

In September 2022, the FDA granted 7 approvals across various cancer types, including durvalumab (Imfinzi) for locally advanced or metastatic biliary tract cancer, eflapegrastim-xnst (Rolvedon) for chemotherapy-induced neutropenia, sodium thiosulfate for pediatric solid tumors, selpercatinib (Retevmo) for advanced or metastatic solid tumors, futibatinib (Lytgobi) for locally advanced or metastatic cholangiocarcinoma, and more.

The FDA also granted 2 orphan drug designations, 1 fast track designation, and approval to an investigational new drug protocol amendment for the phase 1b/2 trial of ABT-101 in patients with non-small cell lung cancer. A supplemental new drug application was submitted to the FDA for rucaparib (Rubraca) as first-line maintenance treatment for patients with advanced ovarian cancer,

Further, the FDA’s Oncologic Drug Advisory Committee met on September 22 and 23, to vote on the risk/benefit profiles of 3 agents. Ultimately, the committee voted against poziotinib non–small cell lung cancer with HER2 exon 20 insertion mutations, melphalan flufenamide (Pepaxto) for relapsed or refractory multiple myeloma, and duvelisib (Copiktra) for patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma. 

Here is a look back at the FDA happenings of September 2022.

FDA Grants Approval to Durvalumab Plus Chemotherapy for Locally Advanced or Metastatic Biliary Tract Cancer

On September 2, the FDA approved durvalumab (Imfinzi) for the treatment of patients with locally advanced or metastatic biliary tract cancer.

FDA Approves a New Pegfilgrastim Biosimilar for Febrile Neutropenia

The FDA granted approval to pegfilgrastim-fpgk (Stimufend), a biosimilar of pegfilgrastim (Neulasta), as a treatment option for patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia on September 7, 2022.

FDA Grants Fast Track Designation to AMB-05X for Tenosynovial Giant Cell Tumor

The FDA granted fast track designation to AMB-05X on September 8, 2022, for the treatment of patients with tenosynovial giant cell tumor of the knee.

FDA Grants Orphan Drug Designation to AVA6000 in Soft Tissue Sarcoma

Also on September 8, 2022, the FDA has granted an orphan drug designation to AVA6000 for the treatment of patients with soft tissue sarcoma.

FDA Approves Eflapegrastim for Chemotherapy-Induced Neutropenia

On September 9, 2022, the FDA approved eflapegrastim-xnst (Rolvedon) injection to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.

FDA Grants Orphan Drug Designation to DUNP19 for Osteosarcoma

The FDA granted an orphan drug designation to the LRRC15 antibody DUNP19 on September 13, 2022, for the treatment of patients with osteosarcoma.

sNDA Submitted to the FDA for Rucaparib in Advanced Ovarian Cancer

Also on September 13, 2022, a supplemental new drug application was submitted to the FDA and EMA for rucaparib (Rubraca) as first-line maintenance treatment for patients with advanced ovarian cancer, regardless of their biomarker status, who have responded to first-line platinum-based chemotherapy.

FDA Clears Phase 1/2 Study of ABT-101 in Non–Small Cell Lung Cancer

The FDA granted approval an investigational new drug protocol amendment for the phase 1b/2 trial of ABT-101 in patients with non-small cell lung cancer on September 14, 2022.

FDA Approves Aprepitant Injectable Emulsion to Prevent Postoperative Nausea and Vomiting

On September 20, 2022, the FDA approved aprepitant (Aponvie) injectable emulsion for the prevention of postoperative nausea and vomiting in adult patients.

FDA Approves Pedmark to Reduce Risk of Ototoxicity in Pediatric Solid Tumors

The FDA approved sodium thiosulfate on September 21, 2022, to reduce the risk of ototoxicity associated with cisplatin in pediatric patients with localized, non-metastatic solid tumors who are aged 1 month and older.

FDA Approves Selpercatinib for Adults With RET Fusion+ Advanced/Metastatic Solid Tumors

Also on September 21, 2022, the FDA granted regular approval to selpercatinib (Retevmo) 40 mg & 80 mg capsules for the treatment of adult patients with locally advanced or metastatic solid tumors with a RET gene fusion that have progressed on or following prior systemic treatment or who have no satisfactory alternative treatment options.

FDA’s ODAC Votes That Benefits Do Not Outweigh Risks for Poziotinib in HER Exon 20 Ins+ NSCLC

On September 22, 2022, the Oncologic Drug Advisory Committee voted 9 to 4 that the current benefits of poziotinib did not outweigh its risks for the treatment of patients with non–small cell lung cancer with HER2 exon 20 insertion mutations.

ODAC Votes Against Melphalan Flufenamide in R/R Multiple Myeloma

Then on September 22, 2022, the FDA’s Oncologic Drugs Advisory Committee voted 14 to 2 that melphalan flufenamide (Pepaxto) is not favorable for the currently indicated patient population of adult patients with relapsed or refractory multiple myeloma.

ODAC Votes Against Duvelisib for Relapsed or Refractory CLL/SLL

In an 8 to 4 vote, the FDA’s Oncologic Drug Advisory Committee decided that the benefit/risk profile of duvelisib (Copiktra) is unfavorable for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least 2 prior therapies on September 23, 2022.

FDA Approval Sought for Denileukin Diftitox in Persistent or Recurrent CTCL

A biologics license application was submitted to the FDA on September 28, 2022, for denileukin diftitox (formerly E7777, Ontak), a potential treatment option for patients with persistent or recurrent cutaneous T-cell lymphoma.

FDA Approves Bevacizumab Biosimilar for Six Cancer Types

On September 30, 2022, the FDA granted approval to bevacizumab-adcd (Vegzelma), a biosimilar to bevacizumab (Avastin), for the treatment of 6 types of cancer, including metastatic colorectal cancer, recurrent or metastatic nonsquamous non–small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, persistent, recurrent, or metastatic cervical cancer, and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

FDA Approves Futibatinib for FGFR2+ Advanced Cholangiocarcinoma

The FDA also granted an accelerated approval to futibatinib (Lytgobi) for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma who harbor FGFR2 gene rearrangement, including gene fusions on September 30, 2022.