A Look Back at FDA News from March 2020

Despite unprecedented challenges during the month of March 2020 due to the coronavirus disease 2019 (COVID-19) pandemic, the FDA continued to push forward with several newly approved indications for the treatment of cancer, as well as other designations that could further advance the treatment landscape.

The FDA granted approval to a combination regimen for the treatment of adult patients with multiple myeloma, as well as a combination for the treatment of patients with hepatocellular carcinoma (HCC). In addition, a new dose of a trastuzumab (Herceptin) biosimilar was approved, and adult patients with extensive-stage small cell lung cancer now have a new approved treatment regimen as well.

Among several Fast Track, Priority Review, Breakthrough Therapy, and Orphan Drug designations, the FDA issued a guidance to act as a set of recommendations to maintain the safety of patients enrolled onto trials and the trial’s integrity during the COVID-19 pandemic, and the FDA also provided clearance for the initiation and immediate enrollment pf a new phase II trial exploring leronlimab (PRO-140) in treating patients with COVID-19 who experience mild to moderate respiratory complications.

Take a look back at all the FDA happenings from March 2020:

FDA Accepts BLA and Grants Priority Review to Tafasitamab/Lenalidomide in R/R DLBCL

The FDA granted Priority Review on March 2, 2020, to the newly accepted Biologics License Application (BLA) for tafasitamab and lenalidomide for the treatment of relapsed/refractory diffuse large B-cell lymphoma. The Prescription Drug User Fee Act (PDUFA) target action date was set as August 30, 2020, with no plans for an advisory committee meeting to discuss the application.

FDA Approves Isatuximab Plus Pomalidomide and Dexamethasone in Multiple Myeloma

On March 2, 2020, the FDA has approved the combination of isatuximab-irfc (Sarclisa) with pomalidomide and dexamethasone as treatment of adult patients with multiple myeloma who have received at least 2 prior therapies including lenalidomide (Revlimid) and a proteasome inhibitor.

FDA Grants Fast Track Designation to AL1010 for Adenoid Cystic Carcinoma Indication

The FDA granted a Fast Track Designation to AL101, an injectable small molecule gamma-secretase inhibitor, as treatment of patients with recurrent or metastatic adenoid cystic carcinoma on March 3, 2020, which is currently being evaluated in the phase II ACCURACY study.

FDA Fast Track Designation Granted to Tipifarnib for T-Cell Lymphomas

On March 3, 2020, the FDA granted a Fast Track Designation to tipifarnib for the treatment of adult patients with relapsed or refractory T-cell lymphomas.

FDA Grants Breakthrough Device Designation to GALAD Score for Early Diagnosis of HCC

The FDA granted a breakthrough device designation on March 4, 2020, to the GALAD score (Elecsys), a serum biomarker-based model that predicts the probability that patients with chronic liver disease will develop HCC.

FDA Partially Halts Phase I Study of ACTR707 in Non-Hodgkin Lymphoma

The FDA placed a partial clinical hold on the phase I trial of ACTR707 in combination with rituximab (Rituxan) in patients with relapsed/refractory B-cell lymphoma from Unum Therapeutics, following the submission of a safety report from the company. The FDA notified Unum of the hold verbally on March 4, 2020.

FDA Grants Orphan Drug Designation to Umbralisib in Follicular Lymphoma

On March 5, 2020, the FDA granted an Orphan Drug designation to umbralisib (TGR-1202), an investigational oral PI3K delta inhibitor, as a treatment for patients with follicular lymphoma.

Bevacizumab Biosimilar Under Review by FDA

The FDA accepted a BLA on March 9, 2020, for MYL-1402O, a proposed biosimilar to bevacizumab (Avastin). The BLA seeks approval for the biosimilar as a treatment for multiple types of cancer and the FDA has set an action date goal of December 27, 2020, for a decision on the BLA.

FDA Grants Breakthrough Therapy Designation to JNJ-6372 in mNSCLC

The FDA granted Breakthrough Therapy designation to JNJ-61186372 (JNJ-6372) on March 10, 2020, for the treatment of patients with metastatic non-small cell lung cancer withEGFRexon 20 insertion mutation whose disease has progressed on or after platinum-based chemotherapy.

FDA Approves Nivolumab Plus Ipilimumab in Advanced Hepatocellular Carcinoma

On March 11, 2020, the FDA granted accelerated approval to the combination of nivolumab (Opdivo) and ipilimumab (Yervoy) for the treatment of patients with advanced HCC previously treated with sorafenib (Nexavar).

FDA Grants Fast Track Designation to Balstilimab Plus Zalifrelimab in Relapsed or Refractory Metastatic Cervical Cancer

The FDA granted a Fast Track designation on March 12, 2020, for the evaluation of balstilimab in combination with zalifrelimab for the treatment of patients with relapsed or refractory metastatic cervical cancer

Novel Agent Receives FDA Orphan Drug Designation for GVHD

On March 18, 2020, the FDA granted 2 orphan drug designations to ALPN-101 for both the prevention and treatment of acute graft-versus-host disease (GVHD).

FDA Issues Guidance on Conducting Clinical Trials During COVID-19 Pandemic

The FDA issued a guidance on March 18, 2020, regarding clinical trials during the COVID-19 pandemic in recognition of the challenges that may impact standard clinical trial procedures. The guidance acts as a set of recommendations to maintain the safety of patients enrolled onto trials and the trial’s integrity. 

Dovitinib Seeking FDA Feedback for Potential RCC Indication

The FDA met with Oncology Venture to discuss a potential path forward for the approval of dovitinib as treatment of patients with renal cell carcinoma (RCC), according to an announcement on March 20, 2020.

FDA Approves New Dose of Biosimilar Ontruzant

On March 24, 2020, the FDA approved a new 420-mg multi-dose vial of Ontruzant (SB3; trastuzumab-dttb), a biosimilar of trastuzumab. This biosimilar product was first approved in January 2019 as a 150-mg single-dose vial for indications including in the adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer, and metastatic gastric or gastroesophageal junction cancer.

FDA Grants IPI-549 and Nivolumab Combo Fast Track Designation for Urothelial Cancer

The FDA granted a fast track designation a combination of novel selective PI3K-gamma inhibitor IPI-549 plus nivolumab (Opdivo) for the treatment of patients with advanced urothelial cancer on March 25, 2020.

FDA Approves Durvalumab for Extensive-Stage Small Cell Lung Cancer

On March 30, 2020, the FDA granted approval to durvalumab (Imfinzi) in combination with standard-of-care chemotherapy, etoposide and carboplatin or cisplatin, as a frontline treatment for adult patients with extensive-stage small cell lung cancer.

FDA Approval Sought for Ide-cel in Relapsed/Refractory Multiple Myeloma

A Biologics License Application was submitted to the FDA on March 31, 2020, for the investigational B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy idecabtagene vicleucel (Ide-cel, bb212) as treatment of patients with multiple myeloma who have received at least 3 prior therapies, which should include an immunomodulatory (IMiD) agent, a proteasome inhibitor, and an anti-CD38 antibody.

FDA Grants Fast Track Designation for ME-401 in Relapsed/Refractory FL

On March 31, 2020, the FDA granted Fast Track Designation to ME-401, an investigational selective oral inhibitor of PI3K inhibitor, as a treatment of patients with relapsed or refractory follicular lymphoma who have received at least 2 prior systemic therapies.

Tivozanib NDA Submitted to FDA for Relapsed or Refractory Renal Cell Carcinoma

On March 31, 2020, a New Drug Applicatoin was submitted to the FDA for the VEGFR tyrosine kinase inhibitor tivozanib (Fotivda) for the treatment of patients with relapsed or refractory RCC.

Leronlimab Continues to Improve Health in Patients with Novel Coronavirus