Here is a look back at the FDA happenings from the month of April 2021.
During April, the FDA granted approvals to 6 therapies across KRAS wild types, triple-negative breast cancer, gastric cancer, endometrial cancer, and B-cell lymphoma. Additionally, the FDA continued the approval of 4 therapies and decided to not continue the approval of 2 other therapies. One accelerated approval was also granted to a therapy for urethral cancer.
Here is a look back at the FDA happenings from the month of April 2021:
On April 1, the FDA has granted breakthrough therapy designation to futibatinib, a covalently binding FGFR inhibitor for the treatment of patients with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements including gene fusions.
A rolling submission of a new drug application has been completed for pacritinib which is seeking FDA approval as a treatment for patients with myelofibrosis who have severe thrombocytopenia on April 1.
A new drug application has been submitted to the FDA on April 1 for the combination of plinabulin and granylocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia.
A proprietary noninvasive test designed to detect pancreatic cancer has been granted breakthrough device designation by the FDA for patients with new-onset diabetes on April 2.
On April 2, a supplemental biologics license application for brexucabtagene autoleucel for the treatment of adult patients with relapsed or refractory B-cell precursors acute lymphoblastic leukemia.
The FDA has administered a breakthrough device designation to ProSense, a liquid-nitrogen based cryoablation system that allows for minimally invasive breast cancer treatment, for the treatment of T1 invasive breast cancer and/or patients not suitable for surgical alternative for breast cancer on April 5.
On April 7, the FDA has issued a letter to the developer of the immunotherapy vaccine, ERC1671, recommending that the phase 2 clinical trial of ERC1671 in combination with granulocyte-macrophage colony-stimulating factor, and cyclophosphamide for the treatment of glioblastoma be terminated.
The FDA has approved a higher dose of cetuximab for the treatmen of patients with KRAS wild-type, EGFR-expressing metastatic colorectal cancer or squamous cell carcinoma of the head and neck April 7.
The FDA granted a regular approval to sacituzumab govitecan on April 7 for the treatment of patients with unresectable locally advanced or metastatic triple-negative breast cancer who have received two or more prior systemic therapies, at least one of them for metastatic disease.
A fast track designation was granted by the FDA to the soluble LAG-3 protein, eftilagimod alpha for the frontline treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma on April 8.
On April 9, the FDA has accepted a biologics license application and granted it a priority review for tisotumab vedotin for the treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
A patient with ovarian cancer has begun treatment with oral endoxifen, an active metabolite of tamoxifen, after a Safe to Proceed Letter was granted by the FDA on April 12.
The FDA on April 13 has granted orphan drug designation to CYNK-001, a non-genetically modified cryopreserved human placental hematopoietic stem cell-derived natural killer cell therapy, for the treatment of patients with malignant gliomas.
An accelerated approval was granted by the FDA to sacituzumab govitecan for the treatment of patients with locally advanced or metastatic urothelial cancer who previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor on April 13.
On April 13, the FDA authorized the marking of GI Genius, the first device that uses artificial intelligence to assist in the diagnosis of colon cancer.
The FDA granted a rare pediatric disease designation to the novel p-STAT3 inhibitor WP1066 for the treatment of patients with the rare brain and spinal cord malignancy, ependymoma on April 14.
On April 16, the FDA approved nivolumab in combination with certain chemotherapies for the initial treatment of advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma on April 16.
On April 16, the FDA lifted a partial clinical hold on a phase 1 clinical trial of SBP-101 in combination with the standard-of-care agents gemcitabine and nab-paclitaxel as treatment of patients with metastatic pancreatic ductal adenocarcinoma.
On April 19, the FDA granted priority review for 2 supplemental biologics license applications for enfortumab vedotin-ejfv for the treatment of a subset of patients with locally advanced or metastatic urothelial cancer.
The FDA granted an orphan drug designation to CA-4948, a first-in-class, small-molecule inhibitor of IRAK4, for the treatment of patients with acute myeloid leukemia and myelodysplastic syndrome on April 19.
On April 20, the FDA granted breakthrough therapy designation to bemarituzumab for the first-line treatment of patients with HER2-negative metastatic and locally advanced gastric and gastroesophageal adenocarcinoma who harbor FGFR2boverexpression or amplification.
On April 21, the FDA has granted a regenerative medicine advanced therapy designation to the allogeneic chimeric antigen receptor T-cell therapy ALLO-715 for the treatment of relapsed or refractory multiple myeloma.
The FDA has granted accelerated approval to dostarlimab-gxly on April 22 for the treatment of adult patients with recurrent or advanced endometrial cancer that has progressed on or following prior treatment with platinum-containing chemotherapy and whose cancers have a specific genetic feature known as dMMR, as determined by an FDA approved test.
On April 23, the FDA has granted priority review to the sterile injectable therapy SH-111 for the treatment of pediatric patients with T-cell leukemia.
On April 23, the FDA has approved the VENTANA MMR RxDX panel, a device that determines if patients with advanced or recurrent endometrial cancer are eligible for treatment with dostarlimab-gxly monotherapy.
The FDA has granted approval top loncastuximab tesirine for the treatment of relapsed or refractory diffuse large B-cell lymphoma, according to a press release from ADC Therapeutics on April 23.
On April 23, the FDA has been leading an industry-wide evaluation of accelerated approvals of oncology drugs for which the clinical benefit was not verified in confirmatory trials.
The FDA has removed the clinical hold on the investigational new drug application of NL-201, a treatment for relapsed or refractory tumors, allowing a phase 1 clinical trial to begin on April 26.
The FDA has granted orphan drug designation to ITIL-168 for the treatment of stage IIB to IV melanoma, an investigational, autologous cell therapy derived from tumor-infiltrating lymphocytes on April 27.
On April 27 the FDA's Oncologic Drugs Advisory Committee voted 7 to 2 in favor of the continued approval of atezolizumab in combination with nab-paclitaxel for the treatment of patients with advanced or metastatic triple-negative breast cancer whose tumors are positive for PD-L1 expression.
The FDA’s Oncologic Drugs Advisory Committee voted 5 to 3 in favor of continued approval of pembrolizumab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who are ineligible for cisplatin-containing chemotherapy on April 28.
The FDA’s Oncologic Drug Advisory Committee voted 10 to 1 to continue the accelerated approval of atezolizumab for the frontline treatment of patients with urothelial cancer who are ineligible for cisplatin on April 28.
On April 29, the FDA’s Oncologic Drugs Advisory Committee has voted 6 to 2 against the continued approval of pembrolizumab as indicated for the treatment of patients with recurrent locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1 who experienced disease progression on or after 2 or more prior lines of therapy,
In an 8 to 0 vote, the FDA’s Oncologic Drug Advisory Committee opted to continue to accelerated approval of pembrolizumab for the treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib on April 29.
On April 30, the FDA has accepted a Biologics License Application for nivolumab for the adjuvant treatment of patients with surgically resected, high-risk muscle-invasive urothelial carcinoma and granted it Priority Review.