Amgen's BiTE for lung cancer backed for EU approval
The EMA's human medicines committee has recommended approval of Amgen's bispecific T-cell engager (BiTE) – Imdylltra – as a second-line treatment option for extensive-stage small cell lung cancer (ES-SCLC).
Imdylltra (tarlatamab) – sold as Imdelltra in some markets – has been backed for use in ES-SCLC patients whose cancer returns or progresses after first-line, platinum-based chemotherapy. The decision by the CHMP ends a long wait for the drug in the EU, coming almost two years after it was first approved in the US and more than a year after it got the green light in the UK.
The drug is a bispecific antibody that targets both the DLL3 protein on cancer cells and the CD3 antigen on T cells, activating the immune system to attack the tumour. Imdylltra is the first drug in the EU to directly target DLL3, a protein that is found in 85-96% of SCLC tumours but is rarely found in healthy cells.
The CHMP's decision is based on the phase 3 DeLLphi-304 study, which showed that the BiTE reduced the risk of death by 40% and significantly extended median overall survival (OS) by more than five months compared to standard of care second-line chemo for ES-SCLC.
The results of the study also prompted the FDA to upgrade its earlier accelerated approval for Imdelltra to a full approval last November. According to Angen, Imdelltra has rapidly become the standard of care in patients with second-line or later SCLC, with sales rising to $627 million last year, up from $115 million in 2024.
Other positive opinions
The CHMP recommended four other new medicines for approval at its March meeting, including:
- Ferring Pharma's adenoviral vector-based gene therapy Adstiladrin (nadofaragene firadenovec) for adults with high-grade, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC);
- Pharming's Joenja (leniolisib) for activated phosphoinositide 3-kinase delta syndrome (APDS), a rare, inherited progressive and potentially life-threatening condition of the immune system, in patients aged 12 and over. A bid to extend the use of the drug to under-12s was turned down in the US last month; and
- Proveca Pharma's Bopediat (furosemide), an orodispersible tablet formulation for oedema (swelling) of cardiac or renal origin, oedema of hepatic origin, and hypertension in children from birth to under 18 years of age with chronic kidney disease (CKD).
Mpox drug should be restricted
The CHMP also recommended that SIGA Technologies' antiviral therapy Tecovirimat SIGA, known as Tpoxx in some markets, should no longer be recommended as a treatment for mpox, a virus that caused a global outbreak in 2022-2024.
The CHMP said that a review of data from four studies carried out in different regions showed that treatment with Tecovirimat SIGA did not heal lesions faster compared with placebo. The drug is still approved for other uses, including the treatment of smallpox, cowpox and complications from smallpox vaccines.
