A Look Back at FDA News from October 2021

In October 2021, the FDA granted 6 approval across 5 disease types, including acute lymphoblastic leukemia, node-positive early breast cancer, recurrent or metastatic cervical cancer, non-small cell lung cancer, and chronic myeloid leukemia.

Additionally, the FDA grade 1 breakthrough device designation, 1 orphan drug designation, and 1 breakthrough therapy designation.

FDA sBLA Submission Aims to Expand Axi-Cel Indication to Second-Line Treatment of LBCL

A supplemental biologics license application was submitted to the FDA on October 1 to expand the current indication of axicabtagene ciloleucel (Yescarta) to include the treatment of adults with relapsed or refractory large B-cell lymphoma in the second-line setting.

FDA Approves Brexucabtagene Autoleucel for Adults With Relapsed/Refractory ALL

The FDA granted approval on October 1, to brexucabtagene autoleucel (Tecartus) for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.

FDA Grants Breakthrough Therapy Designation to Trastuzumab Deruxtecan for HER2+ mBC

On October 4, the FDA granted a breakthrough therapy designation to trastuzumab deruxtecan (Enhertu) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received one or more prior anti-HER2-based regimens.

FDA Grants Seventh Regulatory Designation to Repotrectinib for Solid Tumors, NSCLC

The FDA granted a breakthrough therapy designation to repotrectinib (TPX-0005) for the treatment of patients with NRTK-positive, TKI-pretreated advanced solid tumors on October 6.

FDA Grants Breakthrough Device Designation to Alpha DaRT for Recurrent Glioblastoma Multiforme

The FDA granted a breakthrough device designation on October 8 to Alpha Diffusing Alpha-emitters Radiation Therapy for the treatment of patients with recurrent glioblastoma multiforme.

FDA Halts Development of Select Allogeneic CAR T-Cell Therapies Due to Safety Concern

On October 8, the FDA placed a partial clinical hold on all clinical trials for the development allogeneic CAR T-cell therapy sponsored by Allogene Therapeutics, Inc.

FDA Grants RPDD to 177Lu-omburtamab-DTPA For Medulloblastoma

On October 11, the FDA granted a rare pediatric disease designation to 177Lu-omburtamab-DTPA (lutetium-17), a monoclonal B7-H3 antibody for the treatment of pediatric patients with refractory medulloblastoma.

Rusfertide Clinical Trials to Resume After FDA Lifts Hold

Studies involving rusfertide, an injectable synthetic mimetic of hepcidin and natural hormone, can continue after the FDA lifted a clinical hold on the agent on October 12.

FDA Approves Adjuvant Abemaciclib Plus ET for Select Patients With HR+/HER2-, Node-Positive Early Breast Cancer

On October 13, the FDA granted approval to abemaciclib, in combination with endocrine therapy, for the adjuvant treatment of adult patients with hormone receptor-positive, HER2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ≥20% as determined by an FDA-approved test.

FDA Approves Pembrolizumab With Chemotherapy for PD-L1+ Recurrent or Metastatic Cervical Cancer

The FDA granted approval to pembrolizumab in combination with chemotherapy and with or without bevacizumab, for the treatment of patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 with a combined positive score ≥1, as determined by an FDA-approved test on October 13.

LAVA-051 for CLL Granted Orphan Drug Designation by FDA

On October 15, the FDA granted an orphan drug designation to LAVA-051, an agent designed to activate both VyVδ2 T cells and type 1 NKT cells meant to kill CD1d expressing tumor cells, for the treatment of chronic lymphocytic leukemia.

FDA Approves Adjuvant Atezolizumab for PD-L1+ Non–Small Cell Lung Cancer

The FDA granted approval to atezolizumab on October 15 as adjuvant treatment following surgery and platinum-based chemotherapy for people with non-small cell lung cancer whose tumors express PD-L1≥1%, as determined by an FDA-approved test.

PD-1 Assay to Determine Atezolizumab Eligibility Receives FDA Approval for Use in NSCLC

On October 22, the FDA approved of the use of the VENTANA PD-1 Assay as a companion diagnostic test to determine which patients with non-small cell lung cancer are eligible for atezolizumab.

Nemvaleukin Lands FDA Fast Track Designation for Platinum-Resistant Ovarian Cancer

Fast track designation was granted by the FDA on October 25 to the investigational engineer interleukin-2 variant immunotherapy, nemvaleukin alfa (previously ALKS 4230), for use in combination with pembrolizumab as treatment for patients with platinum-resistant ovarian cancer.

Melphalan Flufenamide for R/R MM Pulled from US Market Over Efficacy Concerns

On October 25, the multiple myeloma drug melphalan flufenamide was removed from the United States market by the developer after results of the phase 3 OCEAN study found that the overall survival in the intent-to-treat population had a hazard ratio of 1.104, indicating no improvement in overall survival.

FDA Grants Priority Review to Tisagenlecleucel for R/R Follicular Lymphoma

The FDA accepted and granted priority review to a biologics license application for tisagenlecleucel as a potential treatment for relapsed or refractory follicular lymphoma after 2 lines of therapy on October 27.

FDA, NIH, and 15 Partners Advance Gene Therapy Development in Rare Diseases

The FDA, the National Institutes of Health, and 15 other organizations joined forces on October 28 to accelerate the development of gene therapies to make them available to American patients with rare diseases, a population of about 30 million, according to a press release issued by the FDA.

FDA Approves Asciminib for Adults With Ph+ CML-CP

On October 29, the FDA approved granted both an accelerated approval for asciminib for the treatment of chronic myeloid leukemia for both adult patients with Philadelphia chromosome-positive CML in chronic phase previously treated with two or more tyrosine kinase inhibitors, and full approval for adult patients with Philadelphia-positive+ chronic CML-CP with the T315I mutation.