|Articles|December 2, 2022
A Look Back at FDA News from November 2022
Author(s)Targeted Oncology Staff
Here is a look back at the FDA happenings from the month of November 2022.
In November 2022, the FDA granted approval to 7 therapies for the treatment of various malignancies. Several orphan drug and fast track designations were also granted in addition to a regenerative medicine advanced therapy designation.
The FDA also took action on an agent that was not showing a benefit for patients after being granted accelerated approval and 1 agent for which an application for approval was submitted was denied approval.
Here is a look back at the FDA happenings of September 2022.
On November 2, 2022, the FDA has granted approval to the oral MEK1/2 inhibitor cobimetinib (Cotellic) for the treatment of patients with histiocytic neoplasms, including Erdheim-Chester disease, Rosai-Dorfman disease, and Langerhans cell histiocytosis.
The FDA granted orphan drug designation on November 2, 2022 to OTX-2002, a first-in-class epigenomic controller, for the treatment of patients with hepatocellular carcinoma.
On November 3, 2022, the FDA has granted approval to an abbreviated new drug application for leuprolide acetate injection for patients with advanced prostate cancer.
The FDA has granted a breakthrough therapy designation to elranatamab (PF-06863135) for the treatment of patients with relapsed/refractory multiple myeloma on November 3, 2022. The agent is being investigated in the phase 2 MagnetisMM-3 trial.
On November 8, 2022, the FDA has granted approval to cemiplimab-rwlc (Libtayo) in combination with platinum-based chemotherapy for the treatment of adult patients with advanced non-small cell lung cancer with no EGFR, ALK, or ROS1 aberrations.
The FDA provided strong guidance against ADC Therapeutics submitting a biologics license application for camidanlumab tesirine (ADCT-301) as treatment of patients with relapsed or Hodgkin lymphoma, during a Type C meeting, on November 10, 2022.
On November 10, 2022, the FDA has granted approval to the combination of brentuximab vedotin (Adcetris) plus doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide in pediatric patients aged 2 years and older with previously untreated, high-risk classical Hodgkin lymphoma.
The FDA has granted approval to tremelimumab (Imjudo) in combination with durvalumab (Imfinzi) and platinum-based chemotherapy on November 10, 2022, for the treatment of patients with metastatic non–small cell lung cancer.
At the request of the FDA stated on November 11, 2022, niraparib (Zejula) will have restricted use as a second-line maintenance therapy after platinum-based chemotherapy for patients with deleterious or suspected deleterious germline BRCA mutations.
On November 14, 2022, the FDA has granted accelerated approval to mirvetuximab soravtansine (Elahere) for patients with folate receptor alpha-high platinum-resistant ovarian cancer who have been previously treated with 1 to 3 prior systemic treatments.
The FDA has granted approval to the VENTANA FOLR1 RxDx Assay on November 14, 2022, the first immunohistochemistry companion diagnostic test to aid in identifying patients with epithelial ovarian cancer who are eligible for targeted treatment with mirvetuximab soravtansine-gynx (Elahere).
On November 18, 2022, the FDA has granted approval to a supplemental biologics license application to add a Monday/Wednesday/Friday intramuscular dosing schedule of asparaginase erwinia chrysanthemi-rywn (Rylaze) in combination with a chemotherapy regimen for the treatment of adult and pediatric patients 1 month or older with acute lymphoblastic leukemia and lymphoblastic lymphoma who have developed hypersensitivity to E. coli-derived asparaginase.
The FDA has delayed a biologics license application (BLA) decision for lifileucel (LN-144) on November 18, 2022, which is seeking approval for the treatment of unresectable or metastatic melanoma. The new target action date for lifileucel is the start of 2023.
On November 21, 2022, the FDA has accepted the biologics license application for subcutaneous epcoritamab (DuoBody-CD3xCD20) for the treatment of patients with relapsed/refractory large B-cell lymphoma after 2 or more lines of systemic therapy an granted it priority review.
Drug manufacturer GSK pulled its monotherapy treatment for previously treated adult patients with relapsed or refractory multiple myeloma belantamab mafodotin-blmf (Blenrep) from the market on November 22, 2022, following a request from the FDA.
On November 25, 2022, the FDA issued a complete response letter to Spectrum Pharmaceuticals, Inc. regarding the new drug application seeking approval of poziotinib for the treatment of patients with previously treated locally advanced or metastatic non-small cell lung cancer harboring HER2 exon 20 insertion mutations.
The FDA has granted fast track designation to REM-001 therapy for the treatment of patients with cutaneous metastatic breast cancer on November 28, 2022.
On November 29, 2022, the FDA has granted fast track designation to batiraxcept (AVB-S6-500) for the treatment of patients with advanced or metastatic clear cell renal cell carcinoma who have progressed after 1-2 previous lines of systemic therapy, including immuno-oncology-based and vascular endothelial growth factor tyrosine kinase inhibitor-based therapies.
The FDA granted CB-010, an allogeneic chimeric antigen receptor T-cell therapy regenerative medicine advanced therapy designation on November 29, 2022, for patients with relapsed or refractory large B cell lymphoma and fast track designation for patients with relapsed or refractory B cell non-Hodgkin lymphoma.
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