A Look Back at the FDA News from February 2020

During February 2021, the FDA granted Emergency Use Authorization to the single-shot coronavirus disease 2019 (COVID-19) Johnson & Johnson vaccine. Additionally, the agency approved 5 oncologic therapies for the treatment of metastatic basal cell carcinoma, lung cancer, large b-cell lymphoma, and multiple myeloma.

The agency also granted several accelerated approvals, fast track designations, orphan drug status, and breakthrough therapy designations.

Here is a look back at the FDA happenings from the month of February 2021:

FDA Grants Accelerated Approval to Tepotinib for METex14+ NSCLC

The FDA has granted an accelerated approval to tepotinib for the treatment of adult patients with metastatic non–small cell lung cancer who harbor a MET exon 14 skipping alteration.

FDA Grants Fast Track Designation to TH1902 in SORT1+ Recurrent, Advanced Solid Tumors

The FDA has granted Fast Track designation to the investigational peptide drug conjugate TH1902 for the treatment of patients with sortilin positive recurrent advanced solid tumors that are refractory to standard therapy.

FDA Grants Accelerated Approval to Umbralisib in Relapsed/Refractory MZL and FL

The FDA has granted accelerated approval to umbralisib for the treatment of patients with relapsed or refractory marginal zone lymphoma who have received at least 1 prior regimen with anti-CD20 therapy, and for patients with follicular lymphoma who have received at least 2 prior systemic therapies.

FDA Approves Liso-Cel CAR T-Cell Therapy for Relapsed/Refractory Large B-Cell Lymphoma

The FDA has granted approval to lisocabtagene maraleucel a CD19-targeting chimeric antigen receptor T-cell therapy, for the treatment of adult patients with relapsed or refractory large B-cell lymphoma who have received at least 2 prior lines of systemic therapy.

FDA Grants Orphan Drug Designation to Apatinib in Adenoid Cystic Carcinoma

The FDA has granted Orphan Drug Designation to the small-molecule tyrosine kinase inhibitor apatinib for the treatment of the rare malignancy, adenoid cystic carcinoma.

FDA Grants 2 Breakthrough Therapy Designations to Asciminib in Ph+ CML

The FDA granted Breakthrough Therapy Designation to the novel STAMP inhibitor asciminib for 2 populations of patients with Philadelphia chromosome-positive chronic myeloid leukemia.

FDA Approves Cemiplimab for Locally Advanced and Metastatic Basal Cell Carcinoma

The FDA has approved cemiplimab-rwlc, the PD-1 inhibitor, for the treatment of patients with advanced basal cell carcinoma previously treated with a hedgehog pathway inhibitor or for whom a hedgehog inhibitor is not appropriate.

ODAC Votes to Wait on Neoadjuvant Pembrolizumab Approval in High-Risk TNBC

In a 10 to 0 vote, the FDA’s Oncology Drug Advisory Committee did not support the approval of pembrolizumab (Keytruda) in combination with chemotherapy as neoadjuvant therapy for high-risk, early-stage triple-negative breast cancer.

BLA Submitted to FDA for Tisotumab Vedotin in Recurrent or Metastatic Cervical Cancer

A Biologics License Application was submitted to the FDA for tisotumab vedotin as treatment of patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

FDA Grants ODD to Novel LSD1 Inhibitor in Acute Myeloid Leukemia

The FDA granted Orphan Drug designation to first-in-class LSD1 inhibitor iadademstat, for the treatment of patients with acute myeloid leukemia.

FDA Approves Trilaciclib to Reduce Chemotherapy-Induced Bone Marrow Suppression for ES-SCLC

The FDA has approved trilaciclib (Cosela) as a first-in-class agent to help reduce the frequency of chemotherapy-induced bone marrow suppression in adults receiving chemotherapy for extensive-stage small cell lung cancer.

FDA Grants Sotorasib a Priority Review for KRAS G12C+ Advanced NSCLC

The FDA accepted a new drug application for sotorasib and granted it a priority review for the treatment of patients with KRAS G12C–mutant locally advanced or metastatic non–small cell lung cancer following at least 1 prior systemic treatment.

FDA Grants Priority Review to Vicineum for High-Risk, BCG-Unresponsive NMIBC

The FDA has accepted a Biologic License Application for Vicineum as a treatment option for patients with high-risk, Bacillus Calmette-Guerin-unresponsive non–muscle invasive bladder cancer, and granted it Priority Review.

FDA Accepts sNDA for Zanubrutinib in Adult Waldenström’s Macroglobulinemia

The FDA has accepted a supplemental New Drug Application for zanubrutinib for the treatment of adult patients with Waldenström macroglobulinemia.

Developers Submit BLAs for Enfortumab Vedotin for 2 Urothelial Carcinoma Indications

The submission of 2 Biologic License Applications for enfortumab vedotin-ejfv have been made to the FDA for consideration as treatment of patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor and who are ineligible for cisplatin.

Tebentafusp Granted FDA Breakthrough Therapy Designation for Unresectable or Metastatic Uveal Melanoma

The FDA has granted a Breakthrough Therapy Designation to tebentafusp for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.

FDA Approves Cemiplimab in Frontline PD-L1-High Advanced NSCLC

The FDA has granted approval to cemiplimab-rwlc, for the first-line treatment of patients with advanced non-small cell lung cancer whose tumors have high PD-L1 expression, as determined by an FDA-approved test. Patients must either have metastatic or locally advanced tumors that are not candidates for surgical resection or definitive chemoradiation, and the tumors must not have EGFR, ALK, or ROS1 aberrations.

FDA Grants Priority Review to Ruxolitinib in Steroid-Refractory cGVHD

The FDA has accepted a supplemental New Drug Application for ruxolitinib and granted it Priority Review as a potential treatment option for adult and pediatric patients 12 years and older with steroid-refractory chronic graft-versus-host disease.

FDA Grants Fast Track Designation to GEN-1 for Advanced Ovarian Cancer

A novel DNA-mediated interleukin-12 immunotherapy, GEN-1, had been granted a Fast Track designation by the FDA for the treatment of advanced ovarian cancer.

FDA Approves CDx for Cemiplimab in Non–Small Cell Lung Cancer

The FDA has expanded the use of PD-L1 IHC 22C3 pharmDx assay to include the diagnosis of patients with non-small cell lung cancer, announced the developer, Agilent Technologies, Inc.

FDA Grants Breakthrough Therapy Designation to Tipifarnib in HRAS+ HNSCC

The FDA has granted a Breakthrough Therapy Designation to tipifarnib for the treatment of patients with recurrent or metastatic HRAS-mutant head and neck squamous cell carcinoma with variant allele frequency ≥ 20% after disease progression on platinum-based chemotherapy.

Cabozantinib Lands Breakthrough Therapy Designation in RAI-Refractory Differentiated Thyroid Cancer

The FDA has granted Breakthrough Therapy Designation to cabozantinib for the potential treatment of patients with differentiated thyroid cancer that has progressed following prior therapy and who are radioactive iodine-refractory if eligible for radioactive iodine.

FDA Approves Melflufen Combination for Triple-Class Refractory Multiple Myeloma

The FDA has granted approval to melphalan flufenamide in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody.

FDA Issues EUA for Third COVID-19 Vaccine

The FDA has issued an emergency use authorization for a third vaccine, the Janssen COVID-19 Vaccine, for the prevention of COVID-19 caused by SARS-CoV-2.