A Look Back at the FDA News from June 2021

In June 2021, the FDA approved 4 new drugs and devices in the areas of non–small cell lung cancer, acute lymphoblastic leukemia, lymphoblastic lymphoma, hemoglobinuria, and mastecytosis. Applications for approval were also submitted across many cancer types such as myelofibrosis, breast cancer, and indolent B-cell non-Hodgkin’s lymphoma.

Many orphan drug statuses, breakthrough therapy designations, and biologics license applications were also granted in June. Further, several meetings of the FDA’s Oncologic Drug Advisory Committee resulted in approval reccomendations or decisions for removal non-effective oncologic drugs from the market.

Here is a look back at the FDA news from June 2021.

FDA Grants Priority Review to Plinabulin With G-CSF for Prevention of Chemotherapy-Induced Neutropenia

At the start of the month, the FDA accepted and granted priority review to the new drug application for plinabulin in combination with granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia in patients with cancer.

FDA Approval Sought for Pedmark as Preventative Agent of Cisplatin-Induced Ototoxicity in Localized, Non-Metastatic Solid Tumors

On June 1, a new drug application was also resubmitted to the FDA for Pedmark, a sodium thiosulfate formulation, for the prevention of ototoxicity induced by cisplatin-based chemotherapy in patients under the age of 18 years old with localized, non-metastatic solid tumors.

FDA Approves Guardant360 Liquid Biopsy as CDx for Sotorasib in NSCLC

On June 1, the FDA approved Guardant360, a liquid biopsy companion diagnostic for tumor mutation profiling or comprehensive genomic profiling to identify patients with locally advanced or metastatic non-small cell lung cancer who have a KRAS G12C mutation and may benefit from sotorasib (Lumakras).

FDA Accepts NDA For Pacritinib to Treat Myelofibrosis and Thrombocytopenia

The FDA accepted and granted priority review on June 1, to a new drug application for pacritinib for the treatment of patients with myelofibrosis and severe thrombocytopenia, defined as a platelet count less than 50x109/L.

FDA Grants Priority Review to Plinabulin With G-CSF for Prevention of Chemotherapy-Induced Neutropenia

On June 1, the FDA accepted and granted priority review to the new drug application for plinabulin in combination with granulocyte colony-stimulating factor for the prevention of chemotherapy-induced neutropenia in patients with cancer.

FDA Considering Approval of New Pegfilgrastim Biosimilar for Breast Cancer

The FDA accepted the biologics license application for peg-filgrastim, a proposed pegfilgrastim biosimilar on June 3.

FDA Grants Expanded Approval of Ravulizumab in Paroxysmal Nocturnal Hemoglobinuria for Pediatric Patients

One June 7, the FDA granted the expanded use of ravulizumab-cwvz (Ultomiris) to include the treatment of children aged 1 month and older and adolescents with paroxysmal nocturnal hemoglobinuria.

FDA Pushes Back Approval Decision on Ruxolitinib for Steroid-Refractory cGVHD

On June 9, the FDA extended the review period of the supplemental new drug application for ruxolitinib (Jakafi) as treatment of patients aged 12 years or older with steroid-refractory chronic graft-versus-host disease. The Prescription Drug User Fee Act target action date was moved back 3 months to September 22, 2021, in order to review updated data from the REACH3 trial, which supports the application for FDA approval.

FDA Grants Fast Track Designation to Bemcentinib/PD-L1 Therapy for AXL+ Advanced/Metastatic NSCLC

The FDA granted on June 9, a fast track designation to bemcentinib in combination with an anti-PD-L1 agent as a potential treatment option for patients with AXL-positive advanced or metastatic non-small cell lung cancer.

The designation has been granted for patients without actionable mutations, who experienced disease progression on or after treatment with an anti-PD-L1 agent, with or without chemotherapy as their frontline treatment method. The decision marks the first time in history that AXL-positive disease is recognized as a molecular targetable disease by the FDA.

FDA Approves Avapritinib for Advanced Systemic Mastocytosis

On June 16, the FDA approved the use of avapritinib for patients with advanced systemic mastocytosis, aggressive systemic mastocytosis, systemic mastocytosis with an associated hematological neoplasm, and mast cell leukemia.

ODAC Panel Approves 4 of 6 Anti–PD-1/PD-L1 Drugs in Accelerated Approval Program

On June 16, an FDA Oncologic Drugs Advisory Committee meeting resulted in continued approval for 4 of 6 indications that were discussed, although all 6 indications did not demonstrate clinical benefit in confirmatory studies. The meeting, held April 27-29, evaluated anti–PD-1/PD-L1 drugs that received accelerated approvals through the FDA’s accelerated approval program, a nearly 30-year-old initiative to expedite the approval process.

FDA Accepts BLA For Balstilimab To Treat Recurrent or Metastatic Cervical Cancer

On June 17, the FDA accepted the biologics license application for the anti-PD-1 antibody drug balstilimab for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.

FDA Grants Breakthrough Therapy Designation to 177Lu-PSMA-617 for mCRPC

The FDA granted breakthrough therapy designation on June 17 to 177Lu-PSMA-617, an investigational radioligand therapy for the treatment of metastatic castration-resistant prostate cancer.

FDA Grants Orphan Drug Designation to Gunagratinib for Cholangiocarcinoma

On June 17, the FDA granted an orphan drug designation to gunagratinib (ICP-192) for the treatment of cholangiocarcinoma. Gunagratinib is a selective pan-FGFR inhibitor.

FDA Approval Sought for Copanlisib Plus Rituximab in Relapsed iNHL *

A supplemental new drug application was submitted to the FDA on June 21 seeking approval for the combination of copanlisib (Aiqopa) and rituximab (Rituxan) for the treatment of relapsed indolent B-cell non-Hodgkin’s Lymphoma and is outside of the FDA accelerated approved indication for the treatment of relapsed follicular lymphoma who have received at least 2 prior systemic therapies.

FDA’s ODAC Votes to Defer Approval of Retifanlimab for Patients With Locally Advanced or Metastatic SCAC

On June 24, the FDA’s Oncologic Drug Advisory Committee voted 13 to 4 for the deferral of the FDA approval of retifanlimab (formerly MGA012) for the treatment of patients with locally advanced or metastatic squamous carcinoma of the anal canal who have progressed on or who are intolerant of platinum-based chemotherapy, pending more research.

Adagrasib for KRAS G12C+ Lung Cancer Granted Breakthrough Therapy Designation by FDA

The FDA granted a breakthrough therapy designation to the small-molecule inhibitor of KRAS G12C, adagrasib on June 25, for patients with advanced non-small cell lung cancer with a KRAS G12C mutation following prior systemic treatment.

FDA Grants Fast Track Designation to SNDX-5613 for R/R MLLr and NMP1-Mutant Acute Leukemias

On June 28, the FDA granted fast track designation to SNDX-5613, a highly selective oral menin inhibitor for the treatment of adult and pediatric patients with relapsed or refractory acute leukemias who harbor a mixed lineage leukemia rearranged or nucleophosmin mutation.

Orelabrutinib Lands FDA Breakthrough Therapy Designation for R/R MCL

The FDA granted breakthrough therapy designation on June 28 to orelabrutinib, a Bruton’s tyrosine kinase inhibitor, for the treatment of relapsed or refractory mantle cell lymphoma.

FDA Grants Orphan Drug Status to Devimistat for Biliary Cancer Treatment

The FDA granted orphan drug designation to devimistat for the treatment of patients with biliary cancer on June 29.

FDA Approves Rylaze for Subsets of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma

On the final day in June, the FDA granted approval to asparaginase erwinia chrysanthemi (recombinant)-rywn (Rylaze) for use within a chemotherapy regimen to treat adult and pediatric patients with acute lymphoblastic leukemia and lymphoblastic lymphoma who are allergic to the E. coli-derived asparaginase products that are traditionally used.