MHRA Approves Amgen's Imdyllytra for Adult Small Cell Lung Cancer

Amgen's Imdyllytra (tarlatamab) has been greenlit by the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for the treatment of adult patients suffering from small cell lung cancer (SCLC). This approval specifically targets individuals whose cancer has metastasized either within the lungs or to additional areas of the body, and who have not responded to two previous treatments.

SCLC is one of the primary forms of lung cancer, comprising roughly 15% of all lung cancer cases. This type of cancer is known for its aggressive progression. Imdyllytra, an antineoplastic agent, is administered intravenously. These agents are designed to target and destroy cancer cells that multiply rapidly.

The decision by the MHRA was largely based on promising results from the DeLLphi-301 trial, a mid-stage study that examined the efficacy of Amgen's drug in patients with an extensive-stage form of SCLC who had not achieved success with two or more prior chemotherapy treatments. The trial showed that Imdyllytra had an overall response rate of 40%, with a median duration of response lasting 9.7 months. The UK regulatory body noted these findings as “encouraging,” especially given the limited treatment alternatives available for patients with advanced SCLC, where there is a significant need for more effective solutions.

Julian Beach, the interim executive director of healthcare quality and access at the MHRA, expressed confidence that the drug met the necessary regulatory benchmarks for safety, quality, and effectiveness. He emphasized that, like all medical products, Imdyllytra's safety will continue to be closely monitored.

The UK approval follows a similar authorization by the US Food and Drug Administration (FDA), where the drug was marketed under the name Imdelltra back in May. Both approvals were facilitated through Project Orbis, an international cooperative effort among regulatory agencies designed to expedite the review and approval process for promising cancer medications.

Julian Beach highlighted the importance of international collaboration in accelerating the approval process for innovative cancer treatments, citing this approval as a testament to the effectiveness of Project Orbis in expediting access to potentially life-saving therapies.

In addition to the Imdyllytra approval, Amgen recently secured MHRA approval for another drug, Blincyto (blinatumomab), intended for the treatment of acute lymphoblastic leukemia (ALL). This new authorisation allows for its use in adult patients with Philadelphia chromosome-negative CD19-positive B-cell precursor ALL during the consolidation phase, a part of frontline therapy aimed at eradicating any residual leukemia cells.

Overall, these advancements in drug approvals underscore the ongoing efforts to enhance treatment options for patients with severe and challenging cancers, offering renewed hope for those who have exhausted conventional therapies.