Amgen’s Imdylltra (tarlatamab) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) to treat adults with small cell lung cancer (SCLC).
The drug has been specifically authorised for use in patients whose disease has spread throughout the lungs, to other parts of the body, or both, and who have failed two other types of treatments.
SCLC, one of the two main forms of primary lung cancer, accounts for approximately 15% of all lung cancer diagnoses and progresses rapidly.
Imdylltra is administered as an intravenous infusion and belongs to a class of drugs called antineoplastic agents, which are designed to kill cancer cells that rapidly divide.
The MHRA’s decision was supported by positive results from the mid-stage DeLLphi-301 trial, which evaluated Amgen’s drug in patients with extensive-stage SCLC who had failed two or more prior lines of chemotherapy
Imdylltra demonstrated an overall response rate of 40% and a median duration of response of 9.7 months, which the UK regulator said was “encouraging in patients with advanced SCLC who have limited treatment options and for whom there is a high unmet need for effective treatment options”.
Julian Beach, MHRA interim executive director of healthcare quality and access, said: “We’re assured that the appropriate regulatory standards of safety, quality and efficacy for the approval of [Imdylltra] have been met. As with all products, we will keep its safety under close review.”
The decision comes after the US Food and Drug Administration approved the drug for SCLC under the brand name Imdelltra in May.
Both authorisations were made through Project Orbis, a global partnership between regulatory bodies to review and approve promising cancer drugs.
“This approval is a great example of how international collaboration between trusted regulatory authorities under Project Orbis get can accelerate the approval of promising cancer treatments,” Beach said.
Amgen also recently received MHRA approval for its immunotherapy Blincyto (blinatumomab) in acute lymphoblastic leukaemia (ALL).
The drug was authorised by the regulator last month for use in adults with Philadelphia chromosome-negative CD19-positive B-cell precursor ALL in the consolidation phase, a phase of frontline treatment for ALL which is aimed at killing any remaining leukaemia cells.