A Look Back at the FDA News from August 2020

The month of August 2020 saw 5 FDA approvals, as well as 5 Priority Review designation across solid tumors and hematologic malignancies. The regulatory body also made strives with novel therapies by granting a few agents Fast Track and Orphan Drug designations.

The developer of 1 oncologic drug received a Complete Response Letter from the FDA improved date, and several companies submitted application for approval consideration.

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

FDA Grants Orphan Drug Designation for SM-88 for Treatment of Pancreatic Cancer

On August 3, the FDA has granted an Orphan Drug designation to SM-88, an investigational modified proprietary tyrosine derivative, for the potential treatment of patients with pancreatic cancer.

FDA Grants Fast Track Designation to BST-236 for Older Adults With Acute Myeloid Leukemia

The FDA has granted a Fast Track designation to BST-236 on August 4, a novel proprietary anti-metabolite, for the treatment of patients with acute myeloid leukemia who are 75 years or older or have comorbidities that preclude the use of intensive induction chemotherapy.

FDA Approves Belantamab Mafodotin for Relapsed or Refractory Multiple Myeloma

On August 5, the FDA granted approval to belantamab mafodotin-blmf (GSK2857916; Blenrep), the treatment of patients with relapsed or refractory multiple myeloma who previously received treatment with at least 4 prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

Omburtamab BLA Submitted for FDA Approval in CNS/Leptomeningeal Metastasis From Neuroblastoma

A completed Biologics License Application was submitted to the FDA on August 6 for omburtamab, an investigation monoclonal antibody, which is intended for the treatment of pediatric patients with central nervous system/leptomeningeal metastasis from neuroblastoma.

FDA Approves Guardant360 CDx as Companion Diagnostic for Osimertinib

The FDA approved the Guardant360 CDx liquid biopsy for tumor mutation profiling in patients with any solid malignant neoplasm. This represents the first liquid biopsy companion that is FDA-approved for comprehensive tumor mutation profiling across all solid tumors.

FDA Issues Complete Response Letter Regarding NDA for Pedmark in Cisplatin-Induced Ototoxicity

On August 11, the FDA issued a complete response letter to Fennec Pharmaceuticals Inc, developer of a sodium thiosulfate formulation, Pedmark, which is intended for the treatment of patients aged 18 years or younger with localized, non-metastatic solid tumors, as prevention of cisplatin-induced ototoxicity.

FDA Fast Track Designation Granted to Novel ADC for Heavily Pretreated Platinum-Resistant Ovarian Cancer

The FDA has granted a fast track designation to a novel antibody-drug conjugate, XMT-1536, on August 11, for the treatment of patients with platinum-resistant high-grade serous ovarian cancer who have received up to 3 prior lines of systemic therapy, or for patients who previously received 4 lines of systemic therapy regardless of their platinum status.

FDA Accepts NDA for Umbralisib in Lymphomas, Grants Priority Review for MZL

On August 13, the FDA accepted a New Drug Application for umbralisib (formerly known as TGR-1202) as treatment of patients with previously treated 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.

ODAC Votes Yes to FDA Approval of Remestemcel-L in Pediatric Steroid-Refractory Acute Graft-Versus-Host Disease

The Oncologic Drugs Advisory Committee of the FDA voted 9 to 1 in favor of the approval of remestemcel-L, an allogeneic cell therapy, for the treatment of children with steroid-refractory acute graft-versus-host disease on August 13.

FDA Grants Priority Review to Trilaciclib in Chemotherapy-Treated Small Cell Lung Cancer

On August 17, the FDA granted Priority Review to the New Drug Application for trilaciclib for the treatment of patients with small cell lung cancer who are receiving chemotherapy.

FDA Grants Priority Review to Fixed-Dose Durvalumab in NSCLC and Bladder Cancer

The FDA accepted a Biologics License Application on August 18 for a new 4-week fixed-dose regimen containing durvalumab and granted it Priority Review for the approved indications of non–small cell lung cancer, as well as bladder cancer.

FDA Pauses Phase 1 Trial for P-PSMA-01 in Metastatic Castration-Resistant Prostate Cancer

On August 19, the FDA placed a partial clinical hold on enrollment to the phase 1 P-PSMA-101-001 trial evaluating P-PSMA-01 as treatment of patients with metastatic castration-resistant prostate cancer.

FDA’s Fast Track Designation Granted to Allogeneic CAR Therapy for B-cell Precursor Acute Lymphoblastic Leukemia

The FDA has granted a fast track designation to PBCAR0191, a CD19-directed allogeneic chimeric antigen receptor T-cell therapy, for the treatment of patients with advanced B-cell precursor acute lymphoblastic leukemia on August 19.

FDA Grants Fast Track Designation to Paxalisib in Glioblastoma

On August 20, the FDA granted a Fast Track designation to paxalisib (formerly GDC-0084) for the treatment of patients with newly diagnosed glioblastoma with unmethylated MGMT promotor status who have completed initial radiation and temozolomide.

FDA Approves Daratumumab Plus Kd Regimen in Relapsed/Refractory Multiple Myeloma

The FDA granted approval to the combination of daratumumab plus carfilzomib and dexamethasone on August 20, as treatment of adult patients with relapsed or refractory multiple myeloma who have received up to 3 prior lines of therapy.

FDA Approval Sought for Cabozantinib/Nivolumab in Advanced RCC

On August 24, a supplemental New Drug Application was submitted to the FDA for cabozantinib plus nivolumab as treatment of patients with advanced renal cell carcinoma.

FDA Grants Fast Track to Repotrectinib in NTRK-Positive Advanced Solid Tumors

The FDA granted a Fast Track designation to repotrectinib on August 25 for the treatment of patients with advanced solid tumors that have an NTRK gene fusion and have progressed on at least 1 prior line of chemotherapy and 1 to 2 prior TRK tyrosine kinase inhibitors, leaving them with no satisfactory alternative treatment options.

Tepotinib Granted Priority Review in MET Exon 14+ Metastatic NSCLC

On August 25, the FDA accepted a New Drug Application for tepotinib and granted it priority review for the treatment of adult patients with metastatic non–small cell lung cancer who harbor a mutation that leads to mesenchymal-epithelial transition exon 14 skipping, as detected by an FDA-approved test.

FDA Approves Generic IV Pemetrexed in Advanced or Metastatic Nonsquamous NSCLC

The FDA granted approval to a generic form of the chemotherapy agent pemetrexed on August 26, which is indicated for intravenous administration in patients with locally advanced or metastatic nonsquamous non–small cell lung cancer that have not progressed following 4 cycles of first-line platinum-based chemotherapy.

FDA Approves Liquid Biopsy Companion Diagnostic for Multiple Indications

On August 27, the FDA granted approval to FoundationOne Liquid CDx, a comprehensive liquid biopsy assay for all solid tumors with multiple companion diagnostic indications.

FDA Grants Priority Review to Melflufen for Triple-Class Refractory Multiple Myeloma

The FDA granted Priority Review to melphalan flufenamide in combination with dexamethasone on August 31 for the treatment of adult patients with multiple myeloma, an immunomodulatory agent, and an anti-CD38 monoclonal antibodies.

FDA Grants Fast Track and Orphan Drug Designations to VLS-101 for Treatment of MCL

On August 31, the FDA also granted a Fast Track and Orphan Drug designation to VLS-101 for the treatment of patients with mantle cell lymphoma.