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The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended extensions of therapeutic indications for several oncology medicines, potentially broadening treatment options across colorectal cancer, bladder cancer, breast cancer, lymphoma, lung cancer, melanoma, and leukemia settings. The label expansions involve earlier-line uses, additional patient populations, pediatric extensions, biomarker-defined indications, and perioperative treatment approaches.

Braftovi 

Braftovi (encorafenib, Pierre Fabre), a BRAF inhibitor, received a positive CHMP opinion for use in combination with cetuximab and FOLFOX as first-line treatment of adults with metastatic colorectal cancer with a BRAF V600E mutation.

The extension moves an encorafenib-based regimen into the first-line metastatic colorectal cancer setting. Braftovi is already authorized in combination with cetuximab for adults with BRAF V600E–mutant metastatic colorectal cancer who have received prior systemic therapy, as well as in combination regimens for BRAF-mutant melanoma and BRAF V600E–mutant advanced non-small cell lung cancer (NSCLC).

Enhertu

Enhertu (trastuzumab deruxtecan, Daiichi Sankyo), a HER2-directed antibody-drug conjugate, received a positive CHMP opinion for use as monotherapy in adults with unresectable or metastatic HER2-positive (IHC 3+) solid tumors who have received prior treatment and have no satisfactory treatment options. 

If approved by the European Commission, the new tumor-agnostic indication would broaden the use of Enhertu beyond its existing breast, lung, and gastric cancer indications.

Erbitux 

Erbitux (cetuximab, Merck Europe), an EGFR-targeted monoclonal antibody, received two positive CHMP opinions for use in BRAF V600E–mutant metastatic colorectal cancer. 

One extension covers Erbitux in combination with encorafenib and FOLFOX as first-line treatment for adults with BRAF V600E–mutant metastatic colorectal cancer.

A second extension covers Erbitux in combination with encorafenib for adults with BRAF V600E–mutant metastatic colorectal cancer who have received prior systemic therapy.

Erbitux is already authorized for EGFR-expressing, RAS wild-type metastatic colorectal cancer in selected settings and for squamous cell cancer of the head and neck.

Hetronifly 

Hetronifly (serplulimab, Accord Healthcare), a PD-1 inhibitor, received a positive CHMP opinion for use in combination with carboplatin and nab-paclitaxel as first-line treatment for adults with unresectable, locally advanced or metastatic squamous non-small cell lung carcinoma. 

The extension adds a squamous NSCLC indication to existing oncology indications for Hetronifly, which include extensive-stage small cell lung cancer, nonsquamous NSCLC without EGFR, ALK, or ROS1-positive mutations, and esophageal squamous cell carcinoma with a PD-L1 combined positive score (CPS) ≥ 5.

Iclusig 

The CHMP adopted a new indication and approved a new 5-mg hard capsule formulation for Iclusig (ponatinib, Incyte Biosciences), a BCR-ABL1 tyrosine kinase inhibitor. The new indication covers pediatric patients aged 6 years or older with chronic phase chronic myeloid leukemia who are resistant or intolerant to dasatinib or nilotinib and are not appropriate candidates for subsequent imatinib therapy, or who harbor the T315I mutation.

Iclusig is already authorized in adults with resistant or intolerant chronic myeloid leukemia or Philadelphia chromosome–positive acute lymphoblastic leukemia in specified settings, including disease with the T315I mutation.

Keytruda 

Keytruda (pembrolizumab, MSD), a PD-1 inhibitor, received positive CHMP opinions covering adolescent oncology indications and perioperative bladder cancer treatment.

For Keytruda solution for injection, the CHMP supported extending three existing adult monotherapy indications to adolescents aged 12 years and older: advanced unresectable or metastatic melanoma; adjuvant treatment after complete resection of stage IIB, IIC, or III melanoma; and relapsed/refractory classic Hodgkin lymphoma after autologous stem cell transplant failure or after at least two prior therapies when transplant is not an option.

Separately, the CHMP adopted a new indication for Keytruda in combination with enfortumab vedotin as neoadjuvant treatment, followed by continued adjuvant treatment after radical cystectomy, for adults with resectable muscle-invasive bladder cancer who are ineligible for cisplatin-containing chemotherapy.

Padcev 

Padcev (enfortumab vedotin, Astellas Pharma), a nectin-4–directed antibody-drug conjugate, was endorsed in combination with pembrolizumab as perioperative therapy for adults with resectable muscle-invasive bladder cancer who are ineligible for cisplatin-based chemotherapy. This included neoadjuvant treatment prior to radical cystectomy followed by continued adjuvant therapy post-surgery.

The proposed indication covers neoadjuvant treatment before radical cystectomy followed by continued adjuvant treatment after surgery. Padcev is already authorized in combination with pembrolizumab for first-line treatment of unresectable or metastatic urothelial cancer in adults eligible for platinum-containing chemotherapy, and as monotherapy for locally advanced or metastatic urothelial cancer after prior platinum-containing chemotherapy and PD-1 or PD-L1 inhibitor therapy.

Tepkinly

Tepkinly (epcoritamab, AbbVie), a CD3xCD20 bispecific antibody, was backed in combination with lenalidomide and rituximab for use in adults with relapsed/refractory follicular lymphoma (FL). 

The extension adds a combination option in relapsed/refractory FL. Tepkinly is already authorized as monotherapy for relapsed/refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy and as monotherapy for relapsed/refractory FL after two or more lines of systemic therapy. 

Trodelvy 

Trodelvy (sacituzumab govitecan, Gilead Sciences), a trophoblastic cell surface antigen 2 (Trop-2)–directed antibody-drug conjugate, received an expanded indication as monotherapy for adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic disease and are not eligible for PD-1 or PD-L1 inhibitor therapy.

The extension would move Trodelvy into an earlier metastatic TNBC setting for patients who are not candidates for checkpoint inhibitor therapy. Trodelvy is already authorized for adults with unresectable or metastatic TNBC after two or more prior systemic therapies, including at least one for advanced disease, and for adults with unresectable or metastatic hormone receptor–positive, HER2-negative breast cancer after endocrine-based therapy and at least two additional systemic therapies in the advanced setting.

The latest indication extensions underscore the continued expansion of precision oncology and immunotherapy approaches across multiple tumor types, with regulators increasingly supporting biomarker-driven and earlier-line treatment strategies. For each product, detailed guidance on its use will be included in the updated summary of product characteristics, which will be made available on the EMA website in all official EU languages following European Commission approval of the variation to the marketing authorization.