FDA Approves Osimertinib For Treatment Of Non-Small Cell Lun
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The U.S. Food and Drug Administration has approved Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation.

Tagrisso was evaluated in a randomized, double-blind, placebo-controlled trial of 682 patients with early stage non-small cell lung cancer and epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R mutation-positive who had undergone complete tumor removal. A total of 339 patients received Tagrisso orally once daily and 343 received a placebo following recovery from surgery and standard adjuvant chemotherapy, if given.

The main outcome measure was the amount of time it took for the cancer to come back or for death to occur from any cause (disease-free survival). In the overall trial population, patients who received Tagrisso had an 80% decrease in chance of disease recurrence compared with patients who received a placebo.

The most common side effects of Tagrisso include diarrhea, rash, musculoskeletal pain, dry skin, skin inflammation around nails, sore mouth, fatigue and cough. It should be discontinued if interstitial lung disease. It may also cause inflammation of the cornea and may cause fetal harm when administered to a pregnant woman.

Source:
https://www.fda.gov/news-events/press-announcements/fda-approves-first-adjuvant-therapy-most-common-type-lung-cancer
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