Here is a look back at the FDA happenings from the month of September 2020.
During the month of September 2020, the FDA granted 2 new approvals for the treatment of patients with acute myeloid leukemia and a subset of patients with lung cancer. There were also 3 new Fast Track designations, 3 Breakthrough Therapy designations, 3 Priority Review designations, and 3 Orphan Drug Designations.
On September 1, 2020, the FDA approved the oral hypomethylating agent CC-486 (azacitadine tablets, Onureg) as maintenance for adult patients with acute myeloid leukemia who achieved a first complete remission or with incomplete blood count recovery after intensive induction chemotherapy and who are unable to complete intensive curative therapy.
The FDA granted an Orphan Drug designation on September 1, 2020, to rhenium nanoLiposomes for the treatment of patients with recurrent glioblastoma.
The FDA accepted a supplemental Biologics License Application on September 4, 2020, for axicabtagene ciloleucel (axi-cel; Yescarta) for the treatment of patients with relapsed or refractory follicular lymphoma or marginal zone lymphoma after 2 or more prior lines of systemic therapy.
The FDA approved pralsetinib (formerly BLU-667, Gavreto) for the treatment of adult patients with metastatic RET fusion–positive non–small cell lung cancer on September 4, 2020.
On September 4, 2020, the FDA granted a priority review to pralsetinib (formerly BLU-667; Gavreto) for the treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer as well as for patients with RET fusion–positive thyroid cancer.
A novel Bcl-2 inhibitor, APG-2575, been granted an Orphan Drug designation (ODD) by the FDA for the treatment of patients with chronic lymphocytic leukemia on September 7, 2020.
The FDA granted an Orphan Drug designation on September 3, 2020, to KNO46 for the treatment of thymic epithelial tumors, Alphamab Oncology, developer of this recombinant humanized PD-L1/CTLA-4 bispecific antibody.
The combination of atezolizumab (Tecentriq) and paclitaxel was not effective for the treatment of patients with treatment-naïve inoperable locally advanced or metastatic triple-negative breast cancer, according to an FDA alert released on September 8, 2020, to healthcare professionals and clinical trial investigators in oncology.
On September 8, 2020, a Breakthrough Therapy designation was granted to plinabulin as treatment of chemotherapy-induced neutropenia from both the FDA in the United States and China’s Center for Drug Evaluation of the National Medical Products Administration
A supplemental Biologics License Application was submitted to the FDA on September 10, 2020, seeking approval of a subcutaneous formulation of daratumumab (Darzalex Faspro) with hyaluronidase-fihj as treatment of patients with light chain.
The FDA granted a Breakthrough Therapy designation on September 10, 2020, to toripalimab for the treatment of patients with nasopharyngeal carcinoma, marking the first anti-PD-1 antibody from China to receive this designation
On September 14, 2020, the FDA granted a Fast Track to EPI-7386, a selective androgen receptor inhibitor, which is a potential treatment for adult patients with metastatic castration-resistant prostate cancer that is resistant to standard-of-care therapy.
The FDA granted a Breakthrough Therapy designation to magrolimab as treatment of patients with newly diagnosed myelodysplastic syndrome on September 15, 2020.
On September 22, 2020, the FDA granted a Priority Review designation to idecabtagene vicleucel (ide-cel; BB2121) as treatment of adult patients with multiple myeloma who have received at least 3 prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.
A Biologics License Application was submitted to the FDA on September 21, 2020, for loncastuximab tesirine (Lonca), an antibody-drug conjugate, as treatment of patients with relapsed or refractory diffuse large B-cell lymphoma.
On September 23, 2020, the FDA accepted a supplemental New Drug Application for crizotinib (Xalkori) and granted it a Priority Review as treatment of pediatric patients with relapsed or refractory systemic anaplastic large cell lymphoma that is positive for an ALK alteration.
The FDA granted a Fast Track designation to DKN-01 on September 24, 2020, for the treatment of patients with gastric and gastroesophageal junction adenocarcinoma whose tumors express the protein DKK1, following disease progression on or after prior treatment with fluoropyrimidine- and platinum-containing chemotherapy and, if appropriate, HER2/neu-targeted therapy.
On September 29, 2020, the FDA granted a Fast Track designation to eganelisib (IPI-549) in combination with an immune checkpoint inhibitor and chemotherapy for the first-line treatment of patients with inoperable locally advanced or metastatic triple-negative breast cancer.