Breakthrough in Lung Cancer Treatment: TAGRISSO® Receives Priority Review

Introduction to TAGRISSO® and Its New Priority Review Status

The U.S. Food and Drug Administration (FDA) has given the green light for Priority Review of TAGRISSO® (osimertinib) for patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). This decision marks a pivotal moment in lung cancer treatment, especially for those who have specific genetic mutations such as exon 19 deletions or exon 21 (L858R) mutations.

Pending approval, TAGRISSO® could become the new standard treatment for these patients, following chemoradiotherapy (CRT). The FDA's action date for their regulatory decision is expected in the fourth quarter of 2024.

What is Priority Review?

FDA’s Priority Review status accelerates the review timeline for medications that could offer significant improvements in treatment for serious conditions. TAGRISSO® has already garnered considerable attention, having been granted Breakthrough Therapy Designation (BTD), which speeds up the development and review process.

Both designations highlight the importance of TAGRISSO® as a potentially transformational treatment for lung cancer patients.

Lung Cancer Statistics

Approximately 200,000 people in the U.S. are diagnosed with lung cancer each year, and NSCLC comprises 80-85% of these cases. Among NSCLC patients, 15% have EGFR mutations, which make them ideal candidates for targeted therapies like TAGRISSO®.

Sadly, nearly 20% of these patients are diagnosed with unresectable tumors, which hampers their treatment options. This is where the approval of TAGRISSO® could offer a new beacon of hope.

Results from the LAURA Phase III Trial

The supplemental New Drug Application (sNDA) for TAGRISSO® is supported by data from the LAURA Phase III trial. This study showed that TAGRISSO® reduced the risk of disease progression or death by an impressive 84% compared to a placebo. Median progression-free survival (PFS) was 39.1 months in the TAGRISSO® group versus 5.6 months in the placebo group.

These benefits were observed across various subgroups, including differences in sex, race, and smoking history, underscoring the robust efficacy of the drug.

Safety Profile of TAGRISSO®

TAGRISSO® has been administered as monotherapy in over 100 countries and has consistently demonstrated a favorable safety profile. Common side effects include leukopenia, diarrhea, and skin rash. Rare but severe side effects such as interstitial lung disease and QT interval prolongation have also been noted.

Physicians are advised to monitor patients closely, particularly those with pre-existing cardiac conditions.

TAGRISSO®’s Broad Approval and Applications

TAGRISSO® has several FDA-approved indications, including first-line treatment for locally advanced or metastatic EGFRm NSCLC. It is also approved in conjunction with chemotherapy for specific cases and as adjuvant therapy post-surgery.

This extensive approval showcases TAGRISSO®’s versatility and efficacy across various stages of lung cancer.

Ongoing Research and Future Prospects

AstraZeneca continues to explore new applications for TAGRISSO® through various clinical trials. Ongoing studies include its use in neoadjuvant and early-stage adjuvant settings, as well as trials investigating combination therapies to overcome drug resistance mechanisms.

These efforts indicate a strong commitment to improving lung cancer treatment outcomes through innovative approaches.

Final Thoughts

Dr. Susan Galbraith, Executive Vice President of Oncology R&D at AstraZeneca, emphasized the importance of bringing TAGRISSO® to market as swiftly as possible. She noted that TAGRISSO®'s inclusion as a standard of care could significantly extend patients' progression-free survival rates.

Overall, the impending approval of TAGRISSO® represents a significant advancement in lung cancer treatment, offering new hope for patients and clinicians alike.