New Indication for Xalkori
Under Priority Review, Pfizer’s Orphan-Drug designated kinase inhibitor, Xalkori® (crizotinib) capsules, has received a new indication from the U.S. Food and Drug Administration (FDA). On July 14, 2022, it was approved to treat patients as young as one year old who have inflammatory myofibroblastic tumors (IMT) that test positive for anaplastic lymphoma kinase (ALK), that cannot be removed by surgery, that have recurred or that have become resistant to previous treatment.
An ultra-rare type of nonhereditary tumor, IMT is diagnosed for fewer than 200 patients, mostly children and teens, per year in the U.S. Typically found in the lungs, tumors also can affect other mucosal areas and the tissues that connect abdominal organs. For treating IMT, Xalkori doses for children are based on body surface area (BSA) beginning at 200mg twice a day for a minimum BSA of 0.6m2. The adult dose is 250mg twice a day. Xalkori has additional indications for treating specific patients who have ALK-positive anaplastic large cell lymphoma (ALCL) or non-small cell lung cancer (NSCLC). During treatment, patients should have regular tests of liver function, heart rate and blood pressure.
Fourth COVID-19 Vaccine Receives FDA Emergency Use Authorization
An emergency use authorization (EUA) was granted by the FDA on July 13, 2022, for Novavax’s COVID-19 vaccine, adjuvanted. Given as two intramuscular (IM) injections with the second three weeks after the first, it is indicated to prevent infection with COVID-19 for patients who are at least 18 years old.
In clinical testing of over 17,000 actively inoculated patients, the Novavax vaccine had a 90.4% overall success rate and it was 78.6% successful for patients at least 65 years old. Side effects, which included pain at the injection site, fatigue, headache and fever are similar to those from other vaccines. A few study participants had an increased risk for inflammation of or around the heart, so patients receiving the vaccine should be informed to report any unusual breathing problems, chest pain or heart rhythm changes to a healthcare provider immediately. Unlike the mRNA-based vaccines from Pfizer/BioNTech and Moderna, Novavax uses a more traditional method of incubating the proteins for its vaccine in insect cells. An adjuvant derived from a natural source is added to increase immune response.
Approval from a Centers for Disease Control and Prevention (CDC) committee, scheduled to meet next week, is needed before the vaccine can be released. The U.S. government already has an agreement with Novavax for at least 3.2 million doses.