A look back at all the FDA news that happened in the month of June, including in multiple myeloma, hematology, sarcoma, and lung cancer.
On June 6, the FDA scheduled a public hearing of its Oncologic Drugs Advisory Committee to address a biologics license application (BLA) for tisagenlecleucel-T (CTL019) for patients aged 3 to 25 years with relapsed/refractory B-cell acute lymphoblastic leukemia. The hearing is planned for July 12, 2017.
Daratumumab (Darzalex) was approved by the FDA on June 16 for use in combination with pomalidomide (Pomalyst) and dexamethasone for patients with multiple myeloma who have received at least 2 prior therapies, including a proteasome inhibitor and lenalidomide (Revlimid).
A supplemental BLAfor the use of denosumab (Xgeva) for the prevention of skeletal-related events in patients with multiple myeloma was accepted by the FDA on June 19.
On June 22, subcutaneous rituximab (Rituxan Hycela) was approved by the FDA for the treatment of adults with previously untreated and relapsed or refractory follicular lymphoma, previously untreated diffuse large B-cell lymphoma, and previously untreated and treated chronic lymphocytic leukemia.
The FDA granted an orphan drug designation to the EZH2 inhibitor tazemetostat on June 22 for the treatment of adults withINI1-negative epithelioid sarcoma.
The combination of dabrafenib (Tafinlar) and trametinib (Mekinist) was approved by the FDA on June 22 for the treatment of patients withBRAFV600positive advanced or metastatic non–small cell lung cancer.
ClearLLab multicolor reagents (T1, T2, B1, B2, M) was approved by the FDA on June 29 for the detection of chronic leukemia, acute leukemia, non-Hodgkin lymphoma, multiple myeloma, myelodysplastic syndrome, and myeloproliferative neoplasms.