A Look Back at FDA News in the Month of June
A look back at all the FDA news that happened in the month of June, including in multiple myeloma, hematology, sarcoma, and lung cancer.
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 withBRAFV600positive 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
Nogapendekin Alfa Plus Checkpoint Inhibition Improves Survival in NSCLC
April 25th 2024Following its recent FDA approval in non-muscle-invasive bladder cancer, nogapendekin alfa has also shown overall survival benefits in addition to checkpoint inhibitor therapy in patients with non-small cell lung cancer.
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Emphasizing the Need for NGS in Advanced NSCLC to Determine Treatment
April 23rd 2024During a Case-Based Roundtable® event, Joshua Sabari, MD, led a discussion on the need for next-generation sequencing to determine treatment in patients with EGFR-positive advanced non–small cell lung cancer in the first article of a 2-part series.
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Age, Disease Burden Are Factors in Early Use of Selinexor in Multiple Myeloma
April 22nd 2024During a Case-Based Roundtable® event, Jonathan L. Kaufman, MD, discussed treatment approaches and the tolerability of a selinexor-containing regimen in a patient with relapsed/refractory multiple myeloma in the first article of a 2-part series.
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