The first radioactive drug to treat a certain type of cancer is among the top 3 new drug approvals for cancer.
Here are the other top cancer drug approvals so far in 2018.
1. Lutetium Lu 177 dotatate (Lutathera, Advanced Accelerator Applications) snagged FDA priority review to treat gastroenteropancreatic neuroendocrine tumors (GEP-NETs).
This is the first time a radioactive drug, or radiopharmaceutical, has been approved for the treatment of GEP-NETs, according to FDA. Lutathera is a radioactive drug that works by binding to a part of a cell called a somatostatin receptor, which may be present on certain tumors. After binding to the receptor, the drug enters the cell allowing radiation to cause damage to the tumor cells.
“GEP-NETs are a rare group of cancers with limited treatment options after initial therapy fails to keep the cancer from growing,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a statement from FDA.
2. FDA approved the first drug to treat certain patients with metastatic breast cancer who have a “BRCA” gene mutation.
FDA expanded the approved use of olaparib (Lynparza, AstraZeneca and Merck) beyond ovarian cancer, to include the treatment of patients with certain types of breast cancer that have metastasized and whose tumors have a specific inherited BRCA genetic mutation.
Lynparza is also the first drug in its class (PARP inhibitor) approved to treat breast 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,” said Richard Pazdur, MD, director of FDA’s Oncology Center of Excellence and acting director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, in a statement from FDA. “This approval demonstrates the current paradigm of developing drugs that target the underlying genetic causes of a cancer, often across cancer types.”
3. FDA expanded the indication on cabozantinib (Cabometyx, Exelixis) to treat patients with advanced renal cell carcinoma (RCC). Cabometyx was initially approved in April 2016, to treat patients with advanced RCC who had previously received antiangiogenic therapy.
The new indication, which received FDA priority review, was based on results from the randomized phase 2 CABOSUN trial in patients with previously untreated RCC, which demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus sunitinib (Sutent, Pfizer), a current standard of care.
FDA’s approval of Cabometyx is “a true win for patients in the U.S. with advanced renal cell carcinoma who now have a new first-line treatment option,” said Michael M. Morrissey, PhD, president and CEO of Exelixis, in a statement.