2016 Oncology Drug Approvals Span Multiple Cancers
At the 2017 HOPA Annual Conference, Vivian Park, PharmD, MBA, BCOP, discussed agents approved by the FDA in oncology in 2016.
|The following article features coverage from the 2017 Hematology/Oncology Pharmacy Association (HOPA) Annual Conference in Anaheim, California. Click here to read more of Cancer Therapy Advisor's conference coverage.|
The U.S. Food and Drug Administration (FDA) approved 5 new agents in 5 different disease states and expanded the indications of 11 therapies in oncology in 2016.
The new approvals included rucaparib for BRCA-mutated ovarian cancer, atezolizumab for relapsed/refractory urothelial carcinoma and non-small cell lung cancer (NSCLC), olaratumab for soft tissue sarcoma, defibrotide for severe hepatic veno-occlusive disease (VOD), and venetoclax for relapsed/refractory chronic lymphocytic leukemia with a 17p deletion.
At the 2017 Hematology/Oncology Pharmacy Association (HOPA) Annual Conference, Vivian Park, PharmD, MBA, BCOP, manager of drug policy and training & education at Memorial Sloan Kettering Cancer Center in New York, New York, discussed agents approved by the FDA in oncology in 2016, highlighting notable efficacy and safety data.1
Dr Park noted that the mechanism of action of defibrotide is not well-understood. It should be used only in patients who have severe VOD, so “it is important to establish some unequivocal criteria to make sure patients are eligible for the drug,” she said.
Venetoclax was highly efficacious with an overall response rate of 80%, but Dr Park noted that it “has extensive, extensive list of drug-drug and drug-food interactions, so it is imperative that you get a full history of medications and diet from the patient.”
The indication of daratumumab was expanded from fourth- to second-line treatment of multiple myeloma in combination with dexamethasone and lenalidomide or bortezomib. Dr Park highlighted that “almost 1 of every 2 patients is going to have an infusion reaction” with daratumumab, even if premedication is used.
Nivolumab received several expanded indications for squamous cell carcinoma of the head and neck and classical Hodgkin lymphoma, but was denied approval for the first-line treatment of NSCLC. “It did not meet its primary endpoint of progression-free survival in the CheckMate 026 trial,” Dr Park said.
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Pembrolizumab also received expanded indications for metastatic NSCLC and recurrent or metastatic head, neck squamous cell carcinoma, and Hodgkin lymphoma.
Read more of Cancer Therapy Advisor's coverage of the 2017 Hematology/Oncology Pharmacy Association (HOPA) Annual Conference by visiting the conference page.
- Park V. New drugs 2016. Lecture presented at: 13th Hematology/Oncology Pharmacy Association Annual Conference; March 29-April 1, 2017; Anaheim, CA.