The European Union has granted approval to pharmaceutical company Merck’s Keytruda for use in chemotherapy for the treatment of lung cancer. This marks the first European approval for an anti-PD-1/L1 therapy for resectable non-small cell lung cancer (NSCLC) based on positive overall survival results. Keytruda has already proven effective in treating several types of NSCLC.
The approval allows for Keytruda to be used as a neoadjuvant treatment and later as monotherapy for patients with resectable NSCLC in combination with platinum-containing chemotherapy. It is targeted towards adults who are at high risk of recurrence. The decision was based on the positive results of the Phase III KEYNOTE-671 trial, which showed a significant improvement in overall survival and a reduction in the risk of death by 28%, regardless of PD-L1 status.
Lung cancer remains a significant cause of cancer deaths, accounting for approximately one in five cancer-related deaths in the United States. However, advancements in treatment have led to improvements in survival rates. Keytruda’s approval for this additional indication brings its total number of indications for lung cancer to six.
Merck has been granted approval to market the Keytruda regimen in all 27 European Union member states, as well as Iceland, Liechtenstein, Norway, and Northern Ireland. This decision opens up a significant market for the pharmaceutical company and is expected to contribute to the drug’s sales, which reached $25 billion in 2023 and are predicted to reach $30 billion by 2026.
However, Keytruda is expected to face a patent cliff at the end of the decade, as its patent expires. To mitigate the impact of this expiration, Merck is focusing on developing combined immunotherapy approaches to enhance its targeted therapies. The company also continues to study Keytruda to explore further expansions and indications.
Marjorie Green, the head of oncology at Merck Research Laboratories, expressed excitement about this approval and the company’s plans to pursue the approval of their regimen worldwide. This latest development showcases the potential of Keytruda in improving outcomes for patients with lung cancer.
In conclusion, the European Union’s approval of Merck’s Keytruda for chemotherapy in lung cancer treatment is a significant milestone. It highlights the efficacy of the therapy in improving overall survival and reducing the risk of disease recurrence. With the approval granted in all EU member states and other territories, Merck can expand its market reach and continue to generate significant sales. The impending patent cliff poses challenges, but Merck is actively working on strategies to overcome this hurdle and advance the field of cancer treatment.