The U.S. Food and Drug Administration (FDA) has approved a new tablet for treating pancreatic cancer. Rasonque, developed by Revolution Medicines in California, aims to combat the most common form of pancreatic cancer.
The tablet targets multiple types of a protein called RAS, which promotes tumor growth. It’s taken once daily and offers a new treatment option for patients with advanced pancreatic cancer. The FDA approved Rasonque more than six months ahead of its review deadline.
“Today’s approval provides a critical new option for patients facing an extraordinarily difficult and historically hard-to-treat cancer,” said acting FDA Commissioner Kyle Diamantas. “It is our fundamental duty to deliver more cures and meaningful treatments to patients as quickly as possible.”
Rasonque has been authorized for adults with metastatic pancreatic cancer. This includes cases that haven’t responded to prior treatments or where patients cannot receive certain combination therapies.
Pancreatic adenocarcinoma accounts for about 95% of the 67,000 annual pancreatic cancer cases identified in the U.S., making it one of the deadliest cancers. Although it represents only 3.2% of total cancer diagnoses, its rapid progression leads to a high death rate.
The approval follows a trial involving 500 patients with pre-treated metastatic disease. Those using Rasonque achieved a median overall survival of 13.2 months, compared to 6.7 months for the standard chemotherapy group.
“This drug showed unprecedented results in an area of high unmet need,” said Angelo de Claro, M.D., director of the FDA’s Oncology Center of Excellence.
Rasonque’s approval was expedited through priority review, orphan drug status, and breakthrough therapy designation. The drug was reviewed using the FDA’s National Priority Voucher pilot program to fast-track critical public health treatments.
The FDA had issued a “safe to proceed” letter in May, enabling patients to access the drug before final approval through expanded access protocols.
Clinical trial data indicated that common side effects include rash, diarrhea, mouth sores, nausea, fatigue, vomiting, abdominal pain, fluid retention, reduced appetite, and bleeding.
“Today’s landmark approval is the most significant advance we have seen in the fight against pancreatic cancer, a devastating disease,” noted Anna Berkenblit, M.D., chief scientific and medical officer of the Pancreatic Cancer Action Network.
Rasonque promises improved treatment for pancreatic cancer, offering extended time with loved ones and a better quality of life, as ongoing research seeks even greater progress in cancer treatment.
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