(RxWiki News) The US Food and Drug Administration (FDA) has approved a new treatment for non-small cell lung cancer (NSCLC).
The FDA approved Tagrisso (osimertinib) to be used alongside other cancer medications to treat NSCLC. More specifically, this medication is approved for use in patients with NSCLC whose tumors show a particular kind of genetic mutation.
“With this approval, patients may be treated with this targeted therapy in an earlier and potentially more curative stage of non-small cell lung cancer,” said Dr. Richard Pazdur, director of the FDA’s Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA’s Center for Drug Evaluation and Research.
Tagrisso was first approved in 2018 as a "first-line" treatment for patients with NSCLC that has metastasized (spread) and has tumors with certain genetic mutations. Now, the FDA has approved it as an additional therapy to be used in earlier stages of cancer, more likely before it has spread to other parts of the body.
According to the FDA, roughly 76 percent of lung cancer cases diagnosed in 2020 will be NSCLC. Around 20 percent of the patients with NSCLC will have tumors with genetic mutations that would allow for treatment with Tagrisso. Factoring in numbers of patients whose tumors are removable, that would leave around 10,000 people per year who may be candidates for treatment with this newly approved medication.
For this new approval, Tagrisso was studied in a trial of nearly 700 patients with NSCLC. Compared to patients who received a placebo, those who received Tagrisso saw an 80 percent reduction in the chance that their cancer would come back after surgery to remove the tumors.
Cough, fatigue, sore mouth, skin inflammation around the nails, dry skin, musculoskeletal pain, rash and diarrhea were common side effects of Tagrisso.
The FDA recommended that patients who develop interstitial lung disease stop taking this medication. This drug was also linked to possible issues with the heart's electrical system and heart failure. Tagrisso is not to be used in pregnant women or people with suspected Stevens-Johnson syndrome or erythema multiforme major.
The FDA granted Tagrisso's approval to AstraZeneca.
Talk to your health care provider about the treatment options that are best for you.