FDA Approves Rasonque for Advanced Pancreatic Cancer

The FDA has approved Rasonque (daraxonrasib) to treat adults with advanced pancreatic cancer.

The drug is for people with pancreatic adenocarcinoma that has spread to other parts of the body.

It is used when patients have already tried at least one other therapy or cannot take strong combination cancer treatments.

Pancreatic adenocarcinoma starts in the cells lining the ducts of the pancreas. It accounts for most cases of pancreatic cancer. This type of cancer is often hard to treat because it is usually caught late and grows quickly. Rasonque is a daily tablet that blocks a family of proteins called RAS. These proteins function as key drivers of tumor growth in most people with this disease. By blocking RAS, the medicine helps stop cancer cells from growing.

Why Was It Approved?

The approval was based on a study of 500 adults with advanced pancreatic cancer that had spread. Half of the patients took Rasonque once a day, and the other half received standard chemotherapy treatments.

Patients taking Rasonque lived longer than those taking chemotherapy. Those on Rasonque lived for a median of 13.2 months, compared to 6.7 months for people getting standard chemotherapy. Rasonque also delayed cancer growth. Patients on Rasonque went a median of 7.2 months before their cancer got worse, compared to 3.6 months for those on chemotherapy. And 30% of people taking Rasonque saw their tumors shrink, compared to 11% of those on chemotherapy.During the trial, side effects were common in both groups. Severe nerve damage in the hands and feet was more common with chemotherapy, while skin rashes, mouth sores, and diarrhea happened more often with Rasonque.

What Do I Need to Know?

Rasonque is taken by mouth as a whole tablet once a day, with or without food. Do not chew, crush, or split the tablets. Skin reactions like rashes, dry skin, and itching are very common and can be severe. Healthcare providers recommend using skin creams, limiting time in the sun, and wearing sunscreen with an SPF of 30 or higher to help protect your skin. Rasonque can also cause severe mouth sores or diarrhea. Call your healthcare provider right away if you get severe stomach pain, a new cough, or trouble breathing, as these can be signs of rare but serious complications.

Tell your healthcare provider about all prescription and over-the-counter medicines you take. Some drugs can change how Rasonque works or increase your risk of side effects.This drug can harm a fetus. Both women and men who take Rasonque should use effective birth control during treatment and for a week after their last dose. Women should not breastfeed while taking Rasonque and for a week after stopping.

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