A Look Back at the FDA News from June 2020

In June 2020, the FDA approved 6 drugs across multiple malignancies, a few of which were ahead of the Prescription Drug User Fee Act target action date. The FDA also granted Priority Review to 1 agent in advanced prostate cancer and granted Orphan Drug and Fast Track designations to a slew of oncologic drugs.

June FDA actions also revealed plans to review approval applications, with and without convening the Oncologic Drug Advisory Committee.

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

BLA for Ropeginterferon Alfa-2b as PV Treatment Accepted by the FDA

On June 4, 2020, the FDA accepted a Biologics License Application (BLA) for ropeginterferon alfa-2b, which is intended for the treatment of patients with polycythemia vera in the absence of splenomegaly. A decision on this BLA is expected in early 2021.

Margetuximab Gains FDA Orphan Drug Designation in Gastric/GEJ Cancer

The FDA granted margetuximab an Orphan Drug designation on June 5, 2020, for the treatment of patients with gastric and gastroesophageal junction cancer.

FDA Approves Nivolumab for Unresectable Esophageal Squamous Cell Carcinoma

On June 11, 2020, the FDA granted approval to nivolumab (Opdivo) for the treatment of patients with unresectable advanced, recurrent, or metastatic esophageal squamous cell carcinoma after receiving prior fluoropyrimidine- and platinum-based chemotherapy.

A Pegfilgrastim Biosimilar Has Received Approval from the FDA

The FDA granted approval to pegfilgrastim-apgf (Nyvepria), a biosimilar of pegfilgrastim (Neulasta), on June 11, 2020, which is indicated to decrease the incidence of infection due to febrile neutropenia in patients with non-myeloid malignancies who are receiving myelosuppressive anti-cancer agents associated with a clinically significant incidence of febrile neutropenia.

Berubicin Granted Orphan Drug Designation for Treatment of Malignant Gliomas

On June 12, 2020, the FDA granted Orphan Drug designation to berubicin an anthracycline anticancer drug intended for the treatment of malignant gliomas.

FDA Grants Orphan Drug Designation to DKN-01 for Gastric/GEJ Cancer

The FDA granted an Orphan Drug designation to DKN-01 on June 12, 2020, for the treatment of patients with gastric and gastroesophageal junction cancer.

FDA Grants Breakthrough Therapy Designation to Vorasidenib CDx in IDH1/2-Mutant Low-Grade Gliomas

On June 15, 2020, the Oncomine Precision Assay was granted a Breakthrough Therapy designation by the FDA to detect isocitrate dehydrogenase 1 and 2 mutations in patients with low-grade glioma who may be eligible for treatment with vorasidenib (AG-881), a first-in-class IDH1/IDH2 inhibitor.

FDA Expanded Approval for Preventative Vaccine of HPV-Associated Oropharyngeal and Other Head and Neck Cancers

The FDA approved an expanded indication for GARDASIL 9 on June 15, 2020, for the prevention of oropharyngeal cancers, as well as other head and neck cancers, caused by human papillomavirus types 16, 18, 31, 33, 45, 52, and 58.

Gemtuzumab Ozogamicin FDA Approval Extended to Pediatric CD33-Positive Acute Myeloid Leukemia

On June 16, 2020, The FDA expanded the approval of gemtuzumab ozogamicin (Mylotarg) to include an indication for the treatment of newly diagnosed pediatric patients with CD33-positive acute myeloid leukemia, which includes patients as young as 1 month old.

Liposomal Irinotecan Combo Granted FDA Fast Track Designation for Advanced PDAC

A liposomal irinotecan (Onivyde) combination was granted FDA Fast Track designation on June 17, 2020, for the treatment of untreated and unresectable, locally advanced or metastatic pancreatic ductal adenocarcinoma.

Rolling NDA Submitted to FDA for Umbralisib as Treatment of Marginal Zone, FollicularLymphomas

On June 17, 2020, a rolling submission of a New Drug Application (NDA) was completed, requesting accelerated approval of umbralisib as treatment of patients with previously treated marginal zone lymphoma and follicular lymphoma.

FoundationOne CDx Approved for Detecting TMB-H Solid Tumors Eligible for Pembrolizumab

The FDA approved the use of FoundationOne CDx on July 17, 2020, as a companion diagnostic for pembrolizumab (Keytruda) to identify patients with tumor mutational burden–high solid tumors who would benefit from treatment with the immunotherapy.

Fruquitinib Receives FDA Fast Track Designation for Metastatic Colorectal Cancer

On June 18, 2020, fruquitinib (Frutiga) was granted Fast Track designation for the treatment of patients with metastatic colorectal cancer who have received prior fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy and anti-VEGF therapy, as well as anti-EGFR therapy for RAS wild-type tumors.

FDA’s ODAC to Review Belantamab Mafodotin BLA for R/R Multiple Myeloma

On June 22, 2020, the FDA announced plans to convene a meeting of the Oncologic Drugs Advisory Committee to review the BLA for belantamab mafodotin as treated of patients with relapsed or refractory multiple myeloma

FDA Grants Priority Review to Relugolix for Men With Advanced Prostate Cancer

An oral 120 mg dose of relugolix received a priority review designation on June 22, 2020, from the FDA for the treatment of patients with advanced prostate cancer. The target FDA action date has been set for December 20, 2020.

FDA Approves Selinexor for R/R Diffuse Large B-Cell Lymphoma

On June 22, 2020, the FDA granted an accelerated approval for selinexor for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, who have received at least 2 prior systemic treatments. The indication includes patients with diffuse large B-cell lymphoma that is arising from follicular lymphoma.

FDA Lifts Partial Clinical Hold on Phase II Trial of Lacutamab in T-cell Lymphomas

A partial clinical hold on the phase 2 TELLOMAK clinical trial was removed by the FDA on June 24, 2020, based on a review of further information. The study will now continue to evaluate the efficacy and safety of lacutamab in patients with advanced T-cell lymphomas.

FDA Approves Pembrolizumab for Recurrent or Metastatic Cutaneous Squamous Cell Carcinoma

On June 24, 2020, pembrolizumab received FDA approval for the treatment of patients with recurrent or metastatic cutaneous squamous cell carcinoma that cannot be cured by either surgery or radiation.

FDA Grants Fast Track Designation to Betalutin in R/R Marginal Zone Lymphoma

FDA granted Fast Track designation to lutetium lilotomab satetraxetan on June 29, 2020, for the treatment of adult patients with relapsed or refractory marginal zone lymphoma who have had 2 or more prior lines of systemic therapy.

NDA Seeks Accelerated Approval of CPP-1X/sul for Familial Adenomatous Polyposis

On Jun 29, 2020, a NDA seeking accelerated approval of eflornithine in combination with sulindac for the treatment of adult patients with familial adenomatous polyposis was submitted to the FDA.

FDA Approves Subcutaneous Phesgo Regimen in HER2+ Early Breast Cancer

The FDA granted approval to the combination of pertuzumab, trastuzumab, and hyaluronidase-zzxf by subcutaneous injection, on June 29, 2020, as treatment of patients with HER2-positive breast cancer that has spread to other parts of the body, as well as for the treatment of adult patients with early HER2-positive breast cancer. The approval was also 4 months ahead of the target action date.

FDA Approves Frontline Pembrolizumab for MSI-H/dMMR CRC

On June 29, 2020, the FDA has approved pembrolizumab monotherapy for the frontline treatment of patients with unresectable or metastatic microsatellite instability–high or mismatch repair deficient colorectal cancer.

FDA Grants Orphan Drug Designation to Novel Monoclonal Antibody in Pancreatic Cancer

The FDA granted Orphan Drug Designation to PBP1510 on June 30, 2020, a first-in-class anti-PAUF monoclonal anti-body, for the treatment of patients with pancreatic cancer.

FDA Grants Orphan Drug Designation to Cirmtuzumab in MCL and CLL

On June 30, 2020, the FDA also granted an Orphan Drug designation to the ROR1 antibody cirmtuzumab for the treatment of patients with mantle cell lymphoma and chronic lymphocytic leukemia or small lymphocytic leukemia.

Rolling BLA Initiated for Omburtamab to Treat Pediatric CNS/Leptomeningeal Metastases

A rolling BLA was initiated for omburtamab on June 30, 2020, for the treatment of pediatric patients with central nervous system/leptomeningeal metastases from neuroblastoma.

Avelumab Approved by FDA for the Treatment of Locally Advanced Urothelial Carcinoma

On the last day of June 2020, the FDA approved avelumab (Bavencio) as a frontline maintenance treatment for patients with locally advanced or metastatic urothelial carcinoma who have not progressed with frontline platinum-based chemotherapy.