A Look Back at FDA News from 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.

FDA Approves Cobimetinib for Histiocytic Neoplasms

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.

FDA Grants Orphan Drug Designation to OTX-2002 in HCC

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.

FDA Approves Leuprolide Acetate Injection for Advanced Prostate Cancer

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.

FDA Grants Breakthrough Therapy Designation to Elranatamab for R/R Multiple Myeloma

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.

FDA Approves Cemiplimab-rwlc Plus Chemotherapy With Advanced NSCLC

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.

FDA Advises Against an Approval Filing for Camidanlumab Tesirine to Treat R/R HL

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.

FDA Approves Brentuximab Vedotin for Pediatric Patients With High-Risk Hodgkin Lymphoma

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.

FDA Approves Tremelimumab With Durvalumab and Platinum Chemotherapy for mNSCLC

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.

FDA Requests Limited Use for Niraparib in Patients Without gBRCAm

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.

FDA Approves Mirvetuximab Soravtansine in FRα-High Platinum-Resistant Ovarian Cancer

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.

FDA Approves Mirvetuximab CDx to Identify Patients With Epithelial Ovarian Cancer

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).

FDA Approves New Dosing Schedule for Rylaze in Adult/Pediatric ALL and LBL

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.

FDA Delays BLA for Lifileucel in Patients With Advanced Melanoma

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.

FDA Grants Priority Review to Subcutaneous Epcoritamab for Previously Treated R/R LBCL

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.

FDA Requests Belantamab Mafodotin for R/R Multiple Myeloma Be Pulled From US Market

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.

FDA Denies Approval of Poziotinib for Advanced/Metastatic NSCLC With HER2 Exon 20 Insertions

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.

FDA Grants Fast Track Designation to REM-001 Therapy for Cutaneous mBC

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.

FDA Grants Fast Track Designation to Batiraxcept for Patients With ccRCC

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.

FDA Grants RMAT and Fast Track Designations to Allogeneic CAR T-Cell Therapy for B-NHL

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.