First Adjuvant Treatment for Non-Small Cell Lung Cancer Approved
The U.S. Food and Drug Administration (FDA) announced the approval of Tagrisso (osimertinib) as the first adjuvant treatment for patients with non-small cell lung cancer whose tumors have a specific type of genetic mutation.
In the overall clinical trial population, patients who received Tagrisso had an 80 percent decrease in disease recurrence chance compared with patients who received a placebo, stated the FDA.
“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 Richard Pazdur, M.D., director of the FDA’s Oncology Center of Excellence, in a press statement issued on December 18, 2020.
"Today’s approval of Tagrisso demonstrates how additional research on therapies approved in later stages of cancer can eventually improve treatment options for patients in earlier stages.”
Tagrisso was evaluated in a randomized, double-blind, placebo-controlled trial of 682 patients with early-stage non-small cell lung cancer and 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 primary outcome measure was the amount of time it took for cancer to come back or for death to occur from any cause (disease-free survival).
Although most patients diagnosed with non-small cell lung cancer have unremovable tumors, 30% have the resectable disease; thus, more than 10,000 patients nationwide each year may be candidates for Tagrisso adjuvant therapy after tumor removal.
Tagrisso was approved in 2018 for the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations.
The most common side effects of Tagrisso include diarrhea, rash, musculoskeletal pain, dry skin, skin inflammation around nails, sore mouth, fatigue, and cough. Tagrisso should be withheld if patients develop interstitial lung disease symptoms and permanently discontinued if interstitial lung disease is confirmed.
Tagrisso may affect the heart’s electrical system and cause heart failure issues, so periodic monitoring should be conducted. Tagrisso may also cause inflammation of the cornea.
Tagrisso can cause fetal harm when administered to a pregnant woman; therefore, the pregnancy status of females of reproductive potential should be confirmed before treatment with Tagrisso is started. Tagrisso should be withheld if Stevens-Johnson syndrome or erythema multiforme major is suspected.
Tagrisso received Orphan Drug designation for the treatment of EGFR mutation-positive non-small-cell lung cancer. Orphan Drug designation provides incentives to assist and encourage drug development for rare diseases. Additionally, the agency granted Tagrisso a Breakthrough Therapy designation for this indication.
The FDA approved Tagrisso to AstraZeneca. TAGRISSO is a registered trademark, and AstraZeneca Access 360 is a trademark of the AstraZeneca group of companies.
For this review, FDA collaborated with the Australian Therapeutic Goods Administration, the Brazilian Health Regulatory Agency, Health Canada, Singapore’s Health Sciences Authority, and Switzerland’s Swissmedic. The application reviews are ongoing at the other regulatory agencies.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, other biological products for human use, and medical devices.
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