A Look Back at FDA News in the Month of June

ODAC Hearing Scheduled to Discuss CTL019 in Relapsed/Refractory B-cell ALL

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.

Third Daratumumab Triplet Approved by FDA for Multiple Myeloma

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).

Denosumab sBLA Accepted by FDA for Treatment of Multiple Myeloma

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.

Subcutaneous Rituximab Approved by FDA for Blood Cancers

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.

Tazemetostat Granted Orphan Drug Status by FDA for Soft Tissue Sarcoma

The FDA granted an orphan drug designation to the EZH2 inhibitor tazemetostat on June 22 for the treatment of adults withINI1-negative epithelioid sarcoma.

Dabrafenib/Trametinib Combo Approved by FDA for BRAF+ NSCLC

The combination of dabrafenib (Tafinlar) and trametinib (Mekinist) was approved by the FDA on June 22 for the treatment of patients withBRAFV600—positive advanced or metastatic non–small cell lung cancer.

First Flow Cytometry-Based Diagnostic Approved by FDA for Blood Cancer Detection

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.

First-Line Panitumumab Approved by FDA for RAS Wild-Type mCRC