FDA Approves First Adjuvant Therapy for Most Common Type of Lung Cancer
The U.S. Food and Drug Administration 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.
Lung cancer is the most common cancer type and the leading cause of cancer-related deaths worldwide. In the U.S., approximately 229,000 adults will be diagnosed with lung cancer in 2020, of which 76% of cases will be non-small cell lung cancer. Approximately 20% of patients with non-small cell lung cancer will have epidermal growth factor receptor (EGFR) mutations, which are mutations on a protein that causes rapid cell growth, and consequently, helps cancer spread. Although most patients who are diagnosed with non-small cell lung cancer have unremovable tumors, 30% have resectable disease; thus, more than 10,000 patients nationwide each year may be candidates for Tagrisso as 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 symptoms of interstitial lung disease, and permanently discontinued if interstitial lung disease is confirmed. Tagrisso may affect the heart’s electrical system and can also cause issues such as heart failure 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.
|
