Here is a look back FDA happenings 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.
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.
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.
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.
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.
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.
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.
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.
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.
On November 12, the FDA granted approval to ropeginterferon alfa-2b-njft for the treatment of adults with polycythemia vera.
The FDA granted an orphan drug designation to LYT-200 for the treatment of patients with pancreatic cancer on November 15.
On November 16, the FDA has granted an orphan drug designation to toripalimab for the treatment of esophageal cancer.
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.
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.
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.
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 approval was granted to nab-sirolimus for intravenous use as treatment of patients with advanced malignant perivascular epithelioid cell tumors on November 23.
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
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.
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.
On November 24, BNT111, an immunotherapy agent under investigation in a phase 2 study, was granted fast track designation by the FDA.
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.
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.
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.
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.