A Look Back at the FDA News from July 2021

Here is a look back FDA happenings from July 2021.

In July 2021, the FDA granted approval to 5 therapies that provided new options for oncologists treating patients with urothelial cancer, multiple myeloma, graft-versus-host disease, endometrial cancer, and breast cancer.

One hopeful drug for the treatment of squamous cell carcinoma was denied FDA approval in July, and the FDA flagged a multiple myeloma drug due to patient deaths in a phase 3 clinical trial. Multiple other FDA designations were granted to oncologic agents in July.

Here is a look back FDA news from July 2021:

FDA Approval for Surufatinib Under Consideration for Advanced NETs

At the start of July, the FDA accepted the filing of a new drug application (NDA) for surufatinib (previously HMPL 012) to be indicated as treatment of patients with advanced neuroendocrine tumors. The FDA set a Prescription Drug User Fee Act target action date of April 30, 2022.

FDA Expands Label for Pembrolizumab to Include Treatment of Locally Advanced cSCC

On July 6, the FDA expanded its approval for pembrolizumab (Keytruda) monotherapy to include the treatment of patients with locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation.

FDA Requests Partial Clinical Hold on Melflufen Studies Following Mixed OS Results in R/R Myeloma Subgroups

The FDA placed a partial clinical hold on clinical trials evaluating the first-in-class peptide-drug conjugate, melphalan flufenamide (melflufen;Pepaxto) on July 8, pending a full benefit/risk profile on the agent for use as an early line of therapy in patients with relapsed/refractory multiple myeloma.

FDA Approves Enfortumab Vedotin in Locally Advanced or Metastatic UC

On July 9, the FDA granted approval to enfortumab vedotin (Padcev) for the treatment of adult patients with locally advanced or metastatic urothelial cancer who are previously treated with a PD-1/PD-L1 inhibitor as well as with platinum-based chemotherapy; and are ineligible for cisplatin-containing chemotherapy and have previously received 1 or more prior lines of therapy.

FDA Approves Daratumumab Quadruplet for Previously Treated Multiple Myeloma

On July 12, the FDA granted approval to the combination of daratumumab and hyaluronidase-fihj (Darzalex Faspro) and pomalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy, including lenalidomide and a proteasome inhibitor.

FDA Recommends Including Patients on Trials Regardless of Prior Therapies in the Non-Curative Setting

In a draft guidance for clinical investigators and sponsors released on July 14, the FDA made recommendations on how to expand eligibility to patients with incurable cancer through clinical trial designs of investigational cancer drugs and biological products with the document “Cancer Clinical Trial Eligibility Criteria: Available Therapy in Non-Curative Settings.”

FDA Lifts Partial Clinical from Study of RVU120 in Relapsed/Refractory AML and MDS

On July 15, the FDA has lifted its partial clinical hold on a first-in-human phase 1B study of RVU120, which is an investigation of the agent for the treatment of patients with relapsed or refractory acute myeloid leukemia and high-risk myelodysplastic syndrome.

FDA Approves Belumosudil for Chronic Graft Versus Host Disease

The FDA granted approval to belumosudil (Rezurock) on July 16, for the treatment of adult and pediatric patients 12 years and older with chronic graft-versus-host disease after failure of at least two prior lines of systemic therapy.

FDA Breakthrough Therapy Designation Granted to Venetoclax/Azacitidine for Treatment-Naïve MDS

On July 21, the FDA granted breakthrough therapy designation to the combination of venetoclax and azacitidine for the treatment of adult patients with previously untreated intermediate-, high- and very high-risk myelodysplastic syndromes per the revised International Prognostic Scoring System.

FDA Orphan Drug Designation Granted to Melanoma Drug Alrizomadlin

The FDA also granted an orphan drug designation on July 21, to alrizomadlin (APG-115), an MDM2-p53 inhibitor, for the treatment of stage 2b to 4 melanomas.

UriFind Test for Bladder Cancer Granted FDA Breakthrough Device Designation

On July 21, the UriFind test that utilizes DNA methylation detection for the diagnosis of bladder cancer was granted a breakthrough device designation by the FDA.

FDA Approves Lenvatinib/Pembrolizumab for Select Patients With Advanced Endometrial Cancer

The FDA approved the combination of lenvatinib (Lenvima) and pembrolizumab (Keytruda) on July 22, for the treatment of patients with advanced endometrial cancer that is not microsatellite instability–high or mismatch repair deficient, who have disease progression following prior systemic treatment and who are not candidates for curative surgery or radiation.

FDA Grants Priority Review to NDA for Nab-Sirolimus in Advanced Malignant PEComa

On July 26, the FDA has granted priority review to the new drug application for the nanoparticle albumin-bound mTOR inhibitor, sirolimus albumin-bound nanoparticles for injectable suspension, nab-sirolimus ABI-009 (Fyarro) for consideration as a treatment for patients with advanced malignant perivascular epithelioid cell tumors.

FDA Denies Approval of Retifanlimab for Locally Advanced or Metastatic SCAC Subgroup

The FDA issued a complete response letter to Incyte Corporation on July 26 in response to the Biologics License Application for the PD-L1 inhibitor, retifanlimab (formerly MGA012), for the treatment of adult patients with locally advanced or metastatic squamous cell carcinoma of the anal canal who have progressed on, or who are intolerant of, platinum-based chemotherapy.

FDA Approves Pembrolizumab and Chemotherapy for High-Risk Early-Stage TNBC

On July 27, the FDA has granted approval to pembrolizumab (Keytruda) for the treatment of patients with high-risk early-stage triple-negative breast cancer in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery.

Rare Pediatric Disease Designation Granted to DAY101 for Low-Grade Glioma

DAY101, an investigational, oral, brain-penetrant, and highly selective type II pan-RAF kinase inhibitor for the treatment of rare, pediatric low-grade glioma, was granted a rare pediatric disease designation by the FDA on July 27.

FDA Warns of Death Risk in Ongoing Multiple Myeloma Clinical Trial

On July 29, a warning from the FDA highlighted that an increased rate of death has been observed in patients with multiple myeloma who are undergoing treatment with the FDA-approved agent melphalan flufenamide in combination with dexamethasone in the phase 2 OCEAN clinical trial.

FDA Grants Fast Track Designation to Novel Asparaginase Therapy for ALL Subset

Fast track designation was granted by the FDA to eryaspase on July 30, for the treatment of patients with acute lymphocytic leukemia who have developed hypersensitivity reactions to E. coli-derived pegylated asparaginase.

Gastric Cancer Therapy TST001 Receives FDA Orphan Drug Designation

On July 30, the FDA granted an orphan drug designation to TST001, an anti-Claudin18/2 monoclonal antibody, for the treatment of gastric cancer or gastroesophageal junction.