Tarlatamaba, a new treatment for adult patients with small cell lung cancer (SCLC), has been approved by the Medicines and Healthcare Products Regulatory Agency (MHRA)
This new treatment is for SCLC patients who have spread throughout the lungs or to other body parts.
This was approved on 31 December under project Orbis, a global initiative that allows cancer treatments to be reviewed and approved more rapidly across multiple countries.
Although SCLC is less common than non-small-cell lung cancer, it is a highly aggressive form of lung cancer that often spreads quickly, which can make it difficult to treat.
What is tarlatan, and how does it work?
Tarlatamab belongs in a class of medicine known as antineoplastic agents, which work to target and kill cancer cells that divide quickly.
By approving this drug patients with SCLC now have more treatment options. It is specifically meant for patients who have already received two other types of treatment, such as chemotherapy or immunotherapy, but whose cancer has continued to progress or come back.
The medication is given through an intravenous (IV) line. Patients receive three infusions within the first three weeks, followed by regular infusions every two weeks.
The decision to approve tarlatamab was mainly based on results from a Phase 2 clinical trial that included patients with extensive-stage SCLC.
These patients had either seen their cancer progress after receiving chemotherapy or had experienced a recurrence after previous treatments.
Targeting advanced small cell lung cancer
When testing tarlatamaba, the study showed 40% of patients responded to the treatment.
For those who benefited, the median duration of the response was 9.7 months. While not all patients experienced complete remission, these results are promising, especially for a population facing few alternatives.
Approving tarlatamaba
The approval shows the importance of international collaboration in advancing cancer care. Under Project Orbis, regulatory authorities in different countries can work together to speed up the process of bringing new treatments to market. This approach is especially valuable for cancers like SCLC, where patients often face poor prognosis and limited effective therapies.
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.
“We’re 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.” The UK government reported.
While tarlatamab’s approval is a major step forward, the MHRA has emphasised that safety monitoring will continue.
Offering hope to patients with limited treatment options
As with all new treatments, the drug’s long-term strategy and efficiency will be closely observed to ensure it stays safe, and its effectiveness will continue to be monitored. Hence, it remains an effective option for patients.
Healthcare providers will continue to report any adverse effects or concerns through the MHRA Yellow Card scheme, allowing for real-time data collection and safety assessments.
The approval of tarlatamab offers hope to individuals facing advanced SCLC, providing a new treatment option that may deliver significant benefits where previous therapies have failed.
For patients battling this aggressive cancer, having a viable treatment option that can slow disease progression and extend survival is a significant breakthrough. As more clinical data is collected, tarlatamab may play a crucial role in improving outcomes for patients facing one of the most challenging forms of cancer.
