A Look Back at the FDA News from December 2020

During the month of December 2020, the FDA made the important decision to granted Emergency Use Authorization to 2 vaccines to combat the coronavirus disease (COVID-19) pandemic in the United States. The agency also granted approval to 7 oncologic therapies, bringing much-needed new treatment options to patients with prostate cancer, HER2-positive breast cancer, non-Hodgkin lymphoma, chronic lymphocytic leukemia, multiple myeloma, EGFR-positive non–small cell lung cancer, and chronic myeloid leukemia.

The FDA also granted many other indications in December 2020 to get therapies on their way to the FDA approval stage. One agent did not make the cut in December 2020, causing the FDA to halt a clinical trial.

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

First PSMA-Targeted PET Drug for Prostate Cancer Approved by FDA

On December 2, the FDA approved Gallium 68 PSMA-11 as the first ever drug for PET imaging of PSMA positive lesions in men with prostate cancer.

Approval Application Submitted for Amivantamab in Metastatic EGFR Exon 20+ NSCLC

A Biologics License Application was submitted to the FDA on December 3, seeking approval of amivantamab as treatment of patients with metastatic non–small cell lung cancer harboring EGFR exon 20 insertion mutations whose disease progressed on/after platinum-based chemotherapy.

BLA Delayed for Balstilimab For Treatment of Recurrent/metastatic Cervical Cancer

On December 4, the FDA pushed back its the Biologic License Application filing for the potential approval of balstilimab as treatment of recurrent/metastatic cervical cancer.

FDA Halts Phase 1/2 CAR T-Cell Study in Pancreatic and Prostate Cancer

The phase 1/2 study of the investigational chimeric antigen receptor T-cell agent BPX-601 administered as treatment of patients with previously treated metastatic pancreatic or prostate cancer is no longer active after the FDA place a partial clinical hold on the trial on December 8.

FDA Grants Sotorasib Breakthrough Therapy Designation for Advanced KRAS G12C+NSCLC

On December 8, the FDA granted a Breakthrough Therapy designation to sotorasib for the treatment of patients with locally advanced or metastatic non–small cell lung cancer who harbored a KRAS G12C mutation following at least 1 prior line of systemic therapy.

FDA Grants Emergency Use Authorization to First Vaccine for COVID-19 Prevention

The FDA granted the first Emergency Use Authorization to the vaccine, BNT162b2, for the prevention of COVID-19, which allows for the vaccine to be distributed in the United States for individuals who are at least 16 years or older.

FDA Grants Fast Track Designation to Devimistat in AML

On December 15, the FDA granted a Fast Track designation to devimistat for the treatment of patients with acute myeloid leukemia.

FDA Approves Margetuximab Plus Chemotherapy in HER2+ Metastatic Breast Cancer

The FDA granted approval to the Fc-engineered, monoclonal antibody margetuximab in combination with chemotherapy, as treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease.

Priority Review Granted to Pembrolizumab Combo in Metastatic Esophageal and GEJ Cancer

The FDA granted a Priority Review designation to pembrolizumab on December 17, for potential approval with platinum and fluoropyrimidine-based chemotherapy as frontline treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus and gastroesophageal junction.

FDA Approval Sought for Sotorasib in Patients With KRAS G12C+ Locally Advanced or Metastatic NSCLC

On December 17, A New Drug Application was submitted to the FDA seeking approval of the investigational KRAS G12C inhibitor sotorasib as treatment of patients with KRAS G12C-mutated locally advanced or metastatic non–small cell lung cancer, as determined by an FDA-approved test, following at least 1 prior systemic therapy.

FDA Approves New Rituximab Biosimilar in NHL, CLL, and Other Hematologic Malignancies

The FDA granted approval to rituximab-arrx on December 18, a biosimilar to rituximab as treatment of adult patients with non-Hodgkin lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis, and microscopic polyangiitis.

FDA Approves Oral Relugolix in Advanced Prostate Cancer

On December 18, the FDA has granted approval to oral relugolix as treatment of patients with advanced prostate cancer.

FDA Approves Selinexor Triplet in Multiple Myeloma For Second Line and Beyond

The FDA approved selinexor in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least 1 prior therapy on December 18.

FDA Approves Osimertinib as Adjuvant Therapy for EGFR+ NSCLC

The FDA approved osimertinib on December 18, as an adjuvant therapy for patients with non–small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test, for use following tumor resection.

FDA Approves Ponatinib for CP-CML

On December 18, the FDA has approved ponatinib for the treatment of adult patients with chronic-phase chronic myeloid leukemia with resistance or intolerance of at least 2 prior tyrosine kinase inhibitors.

FDA Issues EAU to Second COVID-19 Vaccine

The FDA issued an emergency use authorization on December 18, for a second vaccine, the mRNA-1273 Moderna COVID-19 Vaccine, for the prevention of coronavirus disease 2019 (COVID-19) in individuals 18 years of age and older.

Rolling BLA Submission Initiated for Cilta-Cel in R/R Multiple Myeloma

On December 21, a rolling submission was initiated for a Biologics License Application, submitting data to the FDA for the potential approval of ciltacabtagene autoleucel for the treatment of adult patients with relapsed and/or refractory multiple myeloma.

FDA Biologics License Application for JZP-458 Initiated for 2 Leukemia Indications

The submission of a Biologics License Application to the FDA was initiated on December 21, seeking approval of JZP-458 as a part of a multi-agent chemotherapy regimen as treatment of adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma who developed hypersensitivity or silent inactivation to E. coli-derived asparaginases.

FDA Updates Prescribing Label for Ibrutinib for Waldenström Macroglobulinemia Indication

On December 23, the FDA updated the prescribing label for the approval of ibrutinib to include efficacy and safety data as combination therapy with rituximab as treatment of patients with Waldenström’s macroglobulinemia.

FDA Grants Frontline Lorlatinib Priority Review for ALK+ NSCLC

At the close of the year, the FDA accepted a supplemental New Drug Application for lorlatinib as a first-line treatment of patients with ALK-positive metastatic non–small cell lung cancer and has granted the supplemental New Drug Application a Priority Review.