A Look Back at the FDA News from March 2021

During March 2021, the FDA granted approval to 9 therapies and 1 assay across the fields of lung cancer, lymphoma, renal cell carcinoma, and gastrointestinal cancers, and more. One prospective approval chronic graft-versus-host disease was postponed by the FDA during March. Still, countless agents were granted orphan drug and breakthrough therapy designations.

Here is a look back at the FDA happenings from the month of March 2020:

FDA Approves Expanded Indication for Lorlatinib for Frontline ALK+ NSCLC

On March 04, the FDA expanded the approval for lorlatinib (Lorbrena) to include an indication for the first-line treatment of patients with ALK-positive non–small cell lung cancer.

FDA Grants Priority Review to Injectable Pafolacianine Sodium to Identify Ovarian Cancer During Surgery

The FDA accepted a new drug application for pafolacianine sodium injection on March 4 and granted it Priority Review as a potential adjunct for identifying ovarian cancer during surgery.

Cavrotolimod Granted Orphan Drug Designation for Merkel Cell Carcinoma

On March 4, the FDA granted an orphan drug designation to cavrotolimod (AST-008), for the treatment of patients with Merkel cell carcinoma.

FDA Approves Axi-Cel for Relapsed/Refractory Follicular Lymphoma in Third-Line or Beyond

The FDA granted an accelerated approval to axicabtagene ciloleucel (Yescarta) on March 6, for the treatment of adult patients with relapsed or refractory follicular lymphoma who have received 2 or more prior lines of systemic therapy.

FDA Granted Orphan Drug Designation to Novel ImPACT Agent in Upper Tract Urothelial Cancer

On the 8th of March, the FDA has granted an orphan drug designation to Padeliporfin Immune Photo Activated Cancer Therapy for the treatment of adult patients with upper tract urothelial cancer.

FDA Approves CDx for Lorlatinib in ALK-Positive Non–Small Cell Lung Cancer

The FDA granted approval to the VENTANA ALK CDx Assay on March 9, as a companion diagnostic to identify patients with ALK-positive non–small cell lung cancer who may be eligible for treatment with the recently approved ALK inhibitor lorlatinib (Lorbrena).

FDA Grants Breakthrough Device Designation the RaDaR Assay for Early-Stage Cancer Detection

On March 10, rhe FDA granted breakthrough device designation for RaDaR assay, a personalized liquid biopsy assay that tracks a set of up to 48 tumor-specific variants in patients with exceptional sensitivity.

FDA Approves Tivozanib as First Therapy for a Relapsed/Refractory Advanced RCC Subgroup

Tivozanib (Fotivda) was granted FDA approval on March 10, as the first therapy for adults with relapsed or refractory advanced renal cell carcinoma who have received two or more prior systemic therapies.

FDA’s Orphan Drug Status Granted to LNS8801 for Metastatic Uveal Melanoma

On March 10, the FDA granted orphan drug designation to the novel GPER agonist, LNS8801, for the treatment of patients with metastatic uveal melanoma.

FDA Grants Orphan Drug Designation to Novel CDK2/4/6 Inhibitor in Malignant Gliomas

The FDA granted orphan drug designation on the 11th of March to the CDK2/4/6 inhibitor, NUV-422, for the treatment of patients with malignant gliomas.

Nemvaleukin for Mucosal Melanoma Granted FDA’s Orphan Drug Status

On March 12, an orphan drug designation was granted by the FDA to nemvaleukin alfa, an interleukin-2 variant immunotherapy for the treatment of mucosal melanoma.

FDA Postpones Approval Decision on Belumosudil for Chronic Graft-Versus-Host Disease

The FDA extended the review period for the new drug application for belumosudil (KD025) on March 12. The drug is being considered as a potential treatment option for patients with chronic graft-versus-host disease.

FDA Grants Fast Track Designation to Poziotinib for Previously Treated HER2 exon 20-Positive NSCLC

On March 11, the FDA has granted a fast track designation to the tyrosine kinase inhibitor, poziotinib for the treatment of previously treated patients with non-small cell lung cancer whose tumors harbor a HER2 exon 20 mutation.

FDA Issues CRL for Ropeginterferon alfa-2b-njft BLA in PV

The FDA has issued a complete response letter on March 14, to PharmaEssentia Corporation for the company’s biologics license application for ropeginterferon alfa-2b-njft as a potential treatment for patients with polycythemia vera.

FDA Grants Belzutifan Priority Review for VHL-Associated RCC

On March 16, the novel, selective hypoxia-inducible factor-2 alpha inhibitor belzutifan (MK-6482) was granted a priority review by the FDA for the treatment of patients with von Hippel-Lindau disease–associated renal cell carcinoma who do not require immediate surgery.

FDA Grants Orphan Drug Designation to ARX788 for HER2+ Gastric Cancer

The FDA granted an orphan drug designation to ARX788 on March 17, for the treatment of patients with HER2-positive gastric cancer.

FDA Grants NK Cell Therapy Fast Track Designation for Recurrent GBM

On March 18, the FDA granted CYNK-001, a natural killer cell therapy, with a fast track designation for the treatment of adult patients with recurrent glioblastoma multiforme.

FDA Approves TheraSphere Y-90 Glass Microspheres for Unresectable HCC

The FDA granted approval to TheraSphere yttrium-90 glass microspheres on March 18, for the treatment of patients with unresectable hepatocellular carcinoma.

FDA Approves Pembrolizumab Triplet for Advanced Esophageal/GEJ Carcinoma

On March 22, the FDA approved pembrolizumab (Keytruda) in combination with platinum and fluoropyrimidine-based chemotherapy for the treatment of patients with metastatic or locally advanced esophageal or gastroesophageal junction carcinoma who are not eligible for surgical resection or definitive chemoradiation.

Breakthrough Device Designations Granted to Novel MRD Test, Signatera

The FDA granted 2 breakthrough device designations to the molecular residual disease test, Signatera on March 24.

FDA Approves Ide-Cel for Relapsed/Refractory Multiple Myeloma

On March 26, The FDA approved idecabtagene vicleucel for the treatment of adult patients with relapsed or refractory multiple myeloma after 4 or more prior therapies, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody.

Rolling BLA for Ublituximab and Umbralisib in CLL Completed for FDA Submission

The rolling submission of a biologics license application for the combination of ublituximab and umbralisib for the treatment of chronic lymphocytic leukemia was completed for submission to the FDA on March 29.

FDA CRL Issued to Pembrolizumab Developer for Early-Stage TNBC Application

The FDA has issued a complete response letter on March 30, to Merck’s supplemental Biologics License Application which sought FDA approval of pembrolizumab for the treatment of patients with high-risk early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment, then as a single agent as adjuvant treatment due to a need to more data.

FDA Approves a Revised Indication for Daunorubicin/Cytarabine for the Treatment of Pediatric AML

On March 31, the FDA revised the approval of daunorubicin and cytarabine to add 2 new indications for the treatment of newly diagnosed therapy-related acute myeloid leukemia or for AML with myelodysplasia-related changes in pediatric patients aged 1 year and older.

FDA Grants Fast Track Designation to Next-Generation Anthracycline for STS Lung Metastases

The FDA granted a fast track designation on March 31 to Annamycin for the treatment of soft tissue sarcoma lung metastases.

FDA Approves Isatuximab With Carfilzomib and Dexamethasone for Adults With R/R Multiple Myeloma

On March 31, the FDA granted approval to the combination of isatuximab added to carfilzomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.

FDA Approval Sought for Pacritinib to Treat Patients with Myelofibrosis and Severe Thrombocytopenia

A rolling submission of a New Drug Application was completed for pacritinib on March 31. The application is seeking FDA approval as a treatment for patients with myelofibrosis who have severe thrombocytopenia.