Drugs

Expanded Use for AstraZeneca’s Lynparza in Breast Cancer

FDA has expanded the approved use of AstraZeneca’s Lynparza (olaparib tablets) to include treating patients with certain types of breast cancer that have metastasized and whose tumors have a specific genetic mutation. The agency says it is the first PARP inhibitor approved to treat breast cancer, and it is the first time any drug has been approved to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation. Patients are selected for treatment based on genetic testing using Myriad Genetic Laboratories’ BRACAnalysis CDx. Lynparza was first approved in 2014 to treat certain patients with ovarian cancer.

“This class of drugs has been used to treat advanced, BRCA-mutated ovarian cancer and has now shown efficacy in treating certain types of BRCA-mutated breast cancer,” FDA’s Oncology Center of Excellence director Richard Pazdur is quoted in a release as saying. “This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types.”

Lynparza works by blocking an enzyme involved in repairing damaged DNA. “By blocking this enzyme, DNA inside the cancerous cells with damaged BRCA genes may be less likely to be repaired, leading to cell death and possibly a slow-down or stoppage of tumor growth,” the agency says.

Expanded approval was based on data from a randomized clinical trial of 302 patients with HER2-negative metastatic breast cancer with a germline BRCA mutation. The median progression-free survival for patients taking Lynparza was seven months compared to 4.2 months for patients taking chemotherapy only.

Common side effects observed include anemia, neutropenia, leukopenia, nausea, fatigue, vomiting, common cold, respiratory tract infection, influenza, diarrhea, joint pain (arthralgia/myalgia), unusual taste sensation (dysgeusia), headache, indigestion, decreased appetite, constipation and inflammation and sores in the mouth (stomatitis). Severe side effects include development of certain blood or bone marrow cancers and inflammation in the lungs (pneumonitis).

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome