A Look Back at FDA News from November 2021

In November 2021, The FDA granted 3 approvals across 3 disease states, including polycythemia vera, renal cell carcinoma, and malignant perivascular epithelioid cell tumors.

Additionally, the FDA granted 1 emergency use authorization, 2 priority reviews, 5 fast track designations, and 5 orphan drug designations.

FDA Considers Parsaclisib for Approval in FL, MZL, and MCL

On November 1, the FDA accepted a new drug application for the investigational PI3Kδ inhibitor, parsaclisib, for the treatment of patients with relapsed or refractory follicular lymphoma, marginal zone lymphoma, and mantle cell lymphoma.

FDA Emergency Use Authorization Granted to Pfizer COVID-19 Vaccine in Children Between 5 and 11

The FDA authorized the use of Pfizer-BioNTech COVID-19 vaccine in children between 5 and 11 years of age, including in those with pediatric cancers on November 1.

FDA Grants Priority Review to Toripalimab +/- Chemotherapy in Advanced NPC

On November 1, the FDA accepted a biologics license application for toripalimab both in combination with gemcitabine and cisplatin for the first-line treatment of patients with advanced recurrent or metastatic nasopharyngeal carcinoma as well as a monotherapy for the second-line or above treatment of recurrent or metastatic nasopharyngeal carcinoma after platinum-containing chemotherapy.

FDA Postpones Decision on Cilta-Cel for Relapsed/Refractory Multiple Myeloma

On November 2, the Prescription Drug User Fee target data for the chimeric antigen receptor T cell therapy ciltacabtagene autoleucel for the treatment of adult patients with relapsed and/or refractory multiple myeloma was extended to February 28, 2022.

Leronlimab Application for Breakthrough Therapy Designation in mTNBC Submitted to FDA

The developers of the CCR5 antagonist leronlimab submitted a breakthrough therapy designation to the FDA for the potential treatment of metastatic triple-negative breast cancer on November 8.

Fast Track Designation Granted to DLBCL SETD2 Inhibitor

On November 8, an FDA fast track designation was granted to EZM0414, a first-in-class, oral SETD2 inhibitor for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma.

FDA Grants Orphan Drug Designation to NK Cell Engager DF1001 for Esophageal

DF1001, a HER2-targeted natural killer cell engager, was granted an orphan drug designation by the FDA for the treatment of esophageal cancer on November 9.

Bemcentinib for NSCLC Granted FDA Fast Track Designation

The FDA granted an FDA fast track designation to bemcentinib in combination with an anti-PD-L1 agent for the treatment of STK11-mutated advanced/metastatic non-small cell lung cancer on November 10.

FDA Approves Ropeginterferon Alfa-2b-njft for Adults With Polcythemia Vera

On November 12, the FDA granted approval to ropeginterferon alfa-2b-njft for the treatment of adults with polycythemia vera.

FDA Grants Orphan Drug Status to LYT-200 for Pancreatic Cancer

The FDA granted an orphan drug designation to LYT-200 for the treatment of patients with pancreatic cancer on November 15.

FDA Grants Orphan Drug Status to PD-1 Blocker Toripalimab for Esophageal Cancer

On November 16, the FDA has granted an orphan drug designation to toripalimab for the treatment of esophageal cancer. 

FDA Approves Adjuvant Pembrolizumab for Renal Cell Carcinoma

The FDA approved adjuvant pembrolizumab on November 18 for the treatment of renal cell carcinoma with an intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.

MT-6402 Lands FDA Fast Track Designation for PD-L1+ Non–Small Cell Lung Cancer

The FDA granted fast track designation to MT-6402 for the treatment of patients with advanced non–small cell lung cancer expressing PD-1 on November 18.

Novel CAR T Agent Granted FDA Orphan Drug Designation for Myeloma

On November 19, the FDA granted an orphan drug designation to GC012F, a FasTCAR-enabled BCMA/CD19 dual targeted chimeric antigen receptor T cell therapy for the treatment of multiple myeloma.

TriNeta Becomes an FDA Breakthrough Device for Early-Stage Breast Cancer Detection

A novel liquid biopsy for the detection of early-stage breast cancer was granted a breakthrough device designation by the FDA on November 19.

FDA Approves Nab-Sirolimus for Advanced Malignant PEComa

FDA approval was granted to nab-sirolimus for intravenous use as treatment of patients with advanced malignant perivascular epithelioid cell tumors on November 23.

FDA Granted RMAT Designation to CTX110 for B-Cell Malignancies

A regenerative medicine advanced therapy designation was granted by the FDA on November 23, to CTX110, an allogeneic chimeric antigen receptor T-cell therapy that targets CD19-positive B-cell malignancies, according to a press release issued by CRISPR Therapeutics

BLA for Beti-Cel in B-thalassemia Accepted for Priority Review by FDA

The newly accepted FDA approval application for betibeglogene autotemcel, which was accepted on November 23, is supported by 5 studies of the agent across all ages of patients. Eighty-nine percent of evaluable patients achieved transfusion independence.

FDA Halts KOMET-001 Study for Acute Myeloid Leukemia Due to Safety

On November 24, the FDA placed a partial clinical hold on the phase 1b KOMET-00 study, which was evaluating treatment with KO-539 in patients with relapsed or refractory acute myeloid leukemia.

FDA Grants Fast Track Designation to Novel I/O Agent for Advanced Melanoma

On November 24, BNT111, an immunotherapy agent under investigation in a phase 2 study, was granted fast track designation by the FDA.

FDA Grants Orphan Drug Designation to Novel CAR T-Cell Therapy for Acute Lymphoblastic Leukemia

A novel chimeric antigen receptor T-cell agent will now be developed in the United States following an orphan drug designation granted by the FDA on November 26.

FDA 'Fast Tracks' Arfolitixorin for Metastatic Colorectal Cancer

The FDA granted a fast track designation to arfolitixorin, stabilized and biologically active pure form of folate, for treatment of patients with metastatic colorectal cancer on November 29.

FDA Grants Priority Review to Olaparib for Adjuvant Treatment BRCA-mutated HER2- High-Risk eBC

The FDA accepted the supplemental new drug application for olaparib and granted it priority review on November 30 for the adjuvant treatment of patients with BRCA-mutated HER2-negative high-risk early breast cancer who have already been treated with chemotherapy either before or after surgery.

FDA Extends Decision on Pacritinib for Patients With MF and Severe Thrombocytopenia

On November 30, the FDA extended the review period of the new drug application for pacritinib as treatment of patients with myelofibrosis and severe thrombocytopenia.