|Articles|October 3, 2022
A Look Back at FDA News from September 2022
Author(s)Jordyn Sava
Here is a look back at the FDA happenings from the month of 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.
On September 2, the FDA approved durvalumab (Imfinzi) for the treatment of patients with locally advanced or metastatic biliary tract cancer.
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.
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.
Also on September 8, 2022, the FDA has granted an orphan drug designation to AVA6000 for the treatment of patients with soft tissue sarcoma.
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.
The FDA granted an orphan drug designation to the LRRC15 antibody DUNP19 on September 13, 2022, for the treatment of patients with osteosarcoma.
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.
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.
On September 20, 2022, the FDA approved aprepitant (Aponvie) injectable emulsion for the prevention of postoperative nausea and vomiting in adult patients.
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.
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.
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.
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.
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.
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.
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.
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.
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