FDA Approves AstraZeneca's Tagrisso in Combination with Chemotherapy for Advanced Lung Cancer Treatment

In a significant advancement in the field of oncology, the U.S. Food and Drug Administration (FDA) has given its approval for the combination of AstraZeneca's cancer drug Tagrisso with chemotherapy. This combination therapy is intended for the treatment of a specific type of lung cancer, signaling a hopeful future for patients and healthcare professionals dealing with this disease. The approval underscores the ongoing efforts to innovate and enhance cancer treatment strategies.

Approval Based on FLAURA2 Phase III Trial

The FDA's approval of the combination of AstraZeneca's Tagrisso (osimertinib) with chemotherapy is specifically for the treatment of adult patients with EGFR mutated non small cell lung cancer (NSCLC). The decision was grounded in the results of the FLAURA2 Phase III trial. This trial demonstrated that Tagrisso with chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy.

More impressively, this new treatment option can delay disease progression by nearly nine additional months, setting a new benchmark with the longest reported progression-free survival benefit in the 1st line advanced setting. The safety profile of Tagrisso with the addition of chemotherapy was generally manageable and consistent with the established profiles of the individual medicines. The trial continues to assess overall survival as a key secondary endpoint.

Tagrisso: A New Standard in Lung Cancer Treatment

Lung cancer is the leading cause of cancer death among both men and women, with the majority of all NSCLC patients being diagnosed with advanced disease. The approval of Tagrisso with the addition of chemotherapy provides a new standard of care approach for these patients.

Results from a prespecified exploratory analysis of patients in the FLAURA2 trial with brain metastases at baseline showed that Tagrisso plus chemotherapy reduced the risk of central nervous system (CNS) disease progression or death by 42% compared to Tagrisso alone. Furthermore, approximately 70% of people diagnosed with lung cancer are diagnosed with advanced NSCLC, and about 15% of NSCLC patients in the US have an EGFR mutation. The approval reinforces Tagrisso as the backbone of EGFR mutated lung cancer treatment either as monotherapy or in combination with chemotherapy.

Future Prospects and Ongoing Investigations

Tagrisso is currently being investigated in the neoadjuvant and adjuvant settings, indicating that the drug may have more potential applications in the field of cancer treatment. In addition, the FDA's approval of Tagrisso with the addition of chemotherapy has led to its inclusion in the NCCN Clinical Practical Guidelines in Oncology as a recommended regimen for patients with NSCLC whose tumors have EGFR exon 19 deletion or exon 21 L858R mutations.

Regulatory applications are also under review in several other countries based on the FLAURA2 results, indicating a potential for wider global use. This approval not only offers hope for patients currently battling this type of lung cancer but also marks a significant milestone in the ongoing fight against cancer on a global scale.

Side Effects and Safety Profile

The most common adverse effects observed in the osimertinib/chemotherapy arm included leukopenia, thrombocytopenia, neutropenia, lymphopenia, and rash. However, the safety profile of Tagrisso with the addition of chemotherapy was generally manageable and consistent with the established profiles of the individual medicines. Discontinuation rates for Tagrisso due to adverse events were low in both arms of the trial, demonstrating the treatment's relative tolerability for patients.