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This approval has been granted under Project Orbis, an innovative programme that allows participating regulators to review and approve applications for promising cancer treatments quickly and efficiently. SCLC is one of the two main forms of primary lung cancer, accounting for around 1 in 7 of all lung cancers. It is less common than non-small-cell lung cancer and spreads more quickly.

Tarlatamab belongs to a group of medicines called antineoplastic agents, which kill cancer cells that rapidly divide.

Tarlatamab can only be prescribed to patients that have previously been treated with two other types of treatments and if those treatments did not work or are no longer working.

Julian Beach, MHRA Interim Executive Director of Healthcare Quality and Access, said:

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.

Were assured that the appropriate regulatory standards of safety, quality and efficacy for the approval of tarlatamab have been met.

As with all products, we will keep its safety under close review.

Tarlatamab is intended to be given through a vein (intravenously) as an infusion on three occasions in the first 3 weeks and then it is expected to be every 2 weeks thereafter.

The efficacy of Tarlatamab was primarily demonstrated in patients enrolled in a phase 2, open label multicentre trial, where tarlatamab was studied in patients with extensive-stage SCLC which had progressed or recurred following two previous lines of chemotherapy (with or without a checkpoint inhibitor).

An overall response rate of 40% was seen, and the median duration of response was 9.7 months. Overall, these results are encouraging in patients with advanced SCLC who have limited treatment options and for whom there is a high unmet need for effective treatment options.

As with any medicine, the MHRA will keep the safety and effectiveness of tarlatamab under close review.? Anyone who suspects they are having a side effect from this medicine are encouraged to talk to their doctor, pharmacist or nurse and report it directly to the MHRA Yellow Card scheme, either through the website (https://yellowcard.mhra.gov.uk/) or by searching the Google Play or Apple App stores for MHRA Yellow Card.???

?ENDS???

Notes to editors???

• The new marketing authorisation was granted on 31 December 2024 to AMGEN LIMITED.

• This product was submitted and approved via a national procedure as part of Project ORBIS.?

• More information can be found in the Summary of Product Characteristics and Patient Information leaflets which will be published on the MHRA Products website within 7 days of approval.?

• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.? All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.?

• The MHRA is an executive agency of the Department of Health and Social Care.?

• For media enquiries, please contact the newscentre@mhra.gov.uk, or call on 02

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