A Look Back at the FDA News from July 2020

July 31, 2020

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

July 2020 was a busy month for the FDA as the regulatory agency granted 3 drug approvals, 2 Priority Reviews, 4 Fast Track designations, 3 Orphan Drug designations, and 3 Breakthrough Therapy designations. The approvals include the combination regimen of decitabine and cedazuridine (Inqovi) for the treatment of adult patients with myelodysplastic syndromes (MDS), chimeric antigen receptor (CAR) T-cell therapy brexucabtagene autoleucel (formerly KTE-X19; Tecartus) for the treatment of adult patients with relapsed or refractory mantle cell lymphoma, and an immunotherapy plus BRAF/MEK inhibitor combination for the treatment of patients with BRAF V600E–mutated advanced melanoma.

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

FDA Approval Sought for Pralsetinib in RET+ Medullary Thyroid Cancer

A New Drug Application (NDA) was submitted to the FDA on July 1, 2020, for pralsetinib (BLU-667) for approval consideration as treatment of patients with advanced or metastatic RET-mutant medullary thyroid cancer and RET fusion–positive thyroid cancers.

FDA Grants Fast Track Designation to Novel Molecule to Treat Glioblastoma

On July 1, 2020, the FDA granted Fast Track designation to the glutamate-binding molecule, anhydrous enol-oxaloacetate, for the treatment of patients with newly diagnosed glioblastoma multiforme.

FDA Removes Partial Clinical Hold on Camidanlumab Tesirine Phase 2 Trial

On July 6, 2020, the FDA lifted a partial clinical hold placed on the phase 2 clinical trial of camidanlumab tesirine in patients with relapsed or refractory Hodgkin lymphoma after ADC Therapeutics submitted further study information to the FDA.

FDA Approves Decitabine Plus Cedazuridine for MDS With Multiple Indications

The FDA granted approval on July 7, 2020, to the combination regimen of decitabine and cedazuridine as treatment of adult patients with MDS. The indications are for the treatment of patients with previously treated or untreated de novo and secondary MDS and patients with intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups.

FDA Places Clinical Hold on MELANI-01 Trial for CAR T-Cell Therapy

On July 7, 2020, the FDA has placed a clinical hold on the MELANI-01 clinical trial evaluating the gene-edited allogeneic CAR T-cell therapy known as UCARTCS1A in patients with myeloma.

FDA Holds Off on Approval of Pembrolizumab/Lenvatinib for Frontline Unresectable HCC

The FDA issued a complete response letter in regard to the applications for potential accelerated approval of pembrolizumab (Keytruda) in combination with lenvatinib (Lenvima) as treatment of patients with previously untreated, unresectable hepatocellular carcinoma, on July 8, 2020.

FDA Grants Priority Review to Pembrolizumab for Relapsed/Refractory Classical Hodgkin Lymphoma

The FDA granted Priority Review to pembrolizumab as treatment of patients with relapsed or refractory classic Hodgkin lymphoma on July 9, 2020.

FDA ODAC Votes in Favor of Belantamab Mafodotin Approval for Relapsed or Refractory Myeloma

On July 14, 2020, the FDA’s Oncologic Drugs Advisory Committee (ODAC) unanimously voted in favor of the benefit observed with belantamab mafodotin (GSK2857916), an investigational immunoconjugate targeting BCMA. The committee decided that the benefits of the drug outweighed the risks as treatment of patients with relapsed/refractory multiple myeloma who previously received therapy with an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

FDA Grants Orphan Drug Designation to APG-2575 for Treatment of Waldenström Macroglobulinemia

On July 15, 2020, the FDA granted an Orphan Drug designation to APG-2575 for the treatment of patients with Waldenström macroglobulinemia, according to a press release. This is the first Orphan Drug designation granted to this BCL-2 inhibitor.

FDA Grants Fast Track Designation to Enzastaurin in Newly Diagnosed Glioblastoma

On July 17, 2020, enzastaurin (DB102), a first-in-class small molecule serine/threonine kinase inhibitor, was granted a Fast Track designation by the FDA for the potential treatment of patients with newly diagnosed glioblastoma multiforme.

FDA Accepts sNDA for Selinexor as Treatment of Patients With Multiple Myeloma

The FDA accepted a supplemental NDA seeking approval of selinexor (Xpovio) as treatment of patients with multiple myeloma following at least 1 prior line of therapy on July 20, 2020.

FDA Clears Phase 2 Study of Abivertinib in Hospitalized Patients With COVID-19

On July 20, 2020, abivertinib (STI-5656) was cleared by the FDA to be investigated in a phase 2 clinical trial for the treatment of hospitalized patients with moderate to severe coronavirus disease 2019 (COVID-19).

FDA Approval Sought for Inolimomab in Steroid-Refractory Acute GVHD

On July 23, 2020, a Biologics License Application (BLA) was submitted to the FDA for inolimomab (Leukotac) as a potential treatment for adult patients with steroid-refractory acute graft-versus-host disease, grade II-IV.

FDA Approves HPV Test With Extended Genotyping Capabilities

The expanded version of the BD Onclarity™ HPV Assay received approval from the FDA on July 23, 2020, for a pre-market approval supplement, making it the only assay approved right now that individually identifies and reports human papillomavirus (HPV) genotypes 31, 51, 52, 33/58, 35/39/68, and 56/59/66, as well as the standard 16, 18, and 45.

FDA Approves KTE-X19 CAR T-Cell Therapy for R/R Mantle Cell Lymphoma

The FDA has approved brexucabtagene autoleucel for the treatment of adult patients with relapsed or refractory mantle cell lymphoma on July 24, 2020.

FDA Grants Orphan Designation to Cobomarsen for T-Cell Lymphomas

On July 23, 2020, the FDA granted an Orphan Drug designation to cobomarsen (MRG-106) for the treatment of patients with T-cell lymphoma.

FDA Grants Fast Track Designation to CMP-001 Combination in Advanced Melanoma

The FDA granted Fast Track designation on July 27, 2020 to CMP-001 in combination with nivolumab (Opdivo) plus ipilimumab (Yervoy).

FDA Grants Orphan Drug Designation to Zenocutuzumab as Treatment of Pancreatic Cancer

The FDA granted an Orphan Drug designation to zenocutuzumab (MCLA-128) for the treatment of patients with pancreatic cancer on July 27, 2020.

FDA Grants Fast Track Designation to BDTX-189 in EGFR/HER2-Mutant Solid Tumors

On July 28, 2020, the FDA granted Fast Track designation to BDTX-189 for the treatment of adult patients with solid tumors harboring an allosteric HER2 mutation or an EGFR or HER2 exon 20 insertion who have progressed following previous treatment and for whom no satisfactory alternative treatments exist.

FDA Grants New Designations to MK-6482 in RCC and VHL Disease

The FDA granted a Breakthrough Therapy designation on July 29, 2020, to MK-6482, a novel HIF-2alpha inhibitor, as treatment of patients with von Hippel-Lindau (VHL) disease–associated renal cell carcinoma who have non-metastatic tumors that measure less than 3 centimeters in size, unless immediate surgery is needed. The FDA has also granted an Orphan Drug designation to MK-6482 for the treatment of VHL disease alone.

FDA Approves Trastuzumab Companion Diagnostic for Detection of HER2 in Breast Cancer

The FDA approved the Ventana HER2 Dual ISH DNA Probe Cocktail assay as a companion diagnostic for trastuzumab (Herceptin) and for the detection of the HER2 biomarker in patients with breast cancer on July 29, 2020.

Updated BLA Submitted for Ide-Cel in Relapsed/Refractory Multiple Myeloma

On July 29, 2020, a BLA was submitted to the FDA for the use of idecabtagene vicleucel (ide-cel; bb2121) for the treatment of adult patients with relapsed or refractory multiple myeloma.

FDA Grants Breakthrough Therapy Designation to Pevonedistat in Higher-Risk MDS

The FDA granted a Breakthrough Therapy designation to the investigational agent pevonedistat as treatment of patients with higher-risk MDS on July 30, 2020.

FDA Grants Breakthrough Therapy Designation to Osimertinib in EGFR+ Lung Cancer

The FDA has granted a Breakthrough Therapy designation on July 30, 2020, to osimertinib (Tagrisso) as adjuvant treatment of patients with stage IB-IIIA EGFR-mutated non–small cell lung cancer following complete tumor resection with curative intent.

Pembrolizumab Plus Chemotherapy on the Road to FDA Approval for mTNBC, Granted Priority Review

The FDA accepted a supplemental BLA (sBLA) for and granted Priority Review to pembrolizumab in combination with chemotherapy, which is intended for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (combined positive score ≥10) on July 30, 2020.

FDA Approval Being Considered for Neoadjuvant/Adjuvant Pembrolizumab +/- Chemo in Early TNBC

On July 30, 2020, the FDA accepted a sBLA submitted for neoadjuvant pembrolizumab combined with chemotherapy and adjuvant pembrolizumab monotherapy for the treatment of patients with high-risk early-stage TNBC.

FDA Approves Atezolizumab Triplet Regimen for Treatment of Advanced BRAF-Mutant Melanoma

On July 30, 2020, the FDA granted approval to atezolizumab (Tecentriq) in combination with cobimetinib (Cotellic) and vemurafenib (Zelboraf) for the treatment of patients with BRAF V600E–mutated advanced melanoma.

FDA Approves Tafasitamab/Lenalidomide for R/R DLBCL

On July 31, 2020, the FDA approved tafasitamab-cxix (Monjuvi) in combination with lenalidomide (Revlimid) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specific, including DLBCL arising from low-grade lymphoma, and patients who are not eligible for autologous stem cell transplant.