What Are Lenvima and Welireg, and Why Does It Matter?
The FDA approved Lenvima (lenvatinib) to be used with Welireg (belzutifan) for adults with advanced kidney cancer. This combination is for patients with clear cell renal cell carcinoma, which is a common type of kidney cancer. It is used after patients have already received an immunotherapy treatment known as a PD-1 or PD-L1 inhibitor.
Lenvima is a targeted therapy that blocks specific signals in the body called kinases. These signals help tumor cells grow and form new blood vessels. By blocking these signals, Lenvima helps slow down the growth and spread of cancer. Welireg targets a different pathway (HIF-2-alpha) to slow tumor growth. Taking both medicines together offers a new option when previous cancer treatments stop working.
Why Was This Treatment Approved?
The FDA approved this combination based on a clinical trial with 747 adults who had advanced kidney cancer. Half of the patients received Lenvima plus Welireg, while the other half received another drug called cabozantinib. The study looked at how long patients lived without their cancer growing or getting worse.
Patients taking Lenvima plus Welireg lived a median of 14.6 months without their cancer growing, compared to 10.6 months for those taking cabozantinib. Also, 53% of patients in the Lenvima plus Welireg group saw their tumors shrink or disappear, compared to 40% in the cabozantinib group. While the combination helped delay cancer progression, it did not show a clear difference in overall survival length compared to cabozantinib. Severe side effects occurred at similar rates in both groups, affecting 84% of patients taking Lenvima plus Welireg and 83% of those taking cabozantinib.
What Do I Need to Know?
Lenvima and Welireg are each taken once a day by mouth, with or without food. If you have trouble swallowing Lenvima capsules whole, they can be dissolved in water or apple juice before drinking.
When taking the two medicines for ccRCC, the most common side effects include low red blood cell counts (anemia), tiredness, high blood pressure, muscle and joint pain, diarrhea, and nausea. Other common issues include lower thyroid hormone levels, low appetite, protein in the urine, rashes, vomiting, weight loss, constipation, stomach pain, and mouth sores. Your healthcare provider will check your blood pressure, liver, kidneys, and thyroid regularly during treatment.
Lenvima and Welireg can cause severe harm to a fetus. If you can get pregnant, you must take a pregnancy test before starting treatment and use effective birth control while taking these drugs and for 30 days after the final dose. You should not breastfeed during treatment and for a week after your last dose.
Always tell your healthcare provider about all medicines and supplements you're taking, along with any health conditions you have, before starting Lenvima and Welireg. Tell your healthcare provider right away if you plan to have any surgery or dental procedures, as Lenvima can affect wound healing and cause jawbone issues. You should stop taking Lenvima at least a week before planned surgeries or dental procedures.