New recommendations by a European panel introduce first-line immunotherapy for hard-to-treat lung, thyroid, and gastrointestinal cancers, particularly in populations with specific genetic drivers or extensive disease.

At its March 2026 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued multiple positive opinions that widen treatment options across advanced solid tumors. Changes include expanded indications for Hetronifly (serplulimab, Accord Healthcare S.L.U.) and Retsevmo (selpercatinib, Eli Lilly Nederland B.V.) in metastatic or locally advanced non-squamous non-small-cell-lung-cancer (NSCLC), esophageal squamous cell carcinoma (ESCC), tumor‑agnostic RET fusion-positive solid tumors, and medullary and differentiated thyroid cancers. These decisions prioritize high-efficacy interventions earlier in the treatment continuum to address the rapid progression often seen in these patient populations.

New Indications for Hetronifly 

The CHMP backed two new expanded indications for Hetronifly, a PD-1 inhibitor:

• NSCLC: Hetronifly was approved for use with carboplatin and pemetrexed as first-line therapy for adults with metastatic or locally advanced non-squamous NSCLC who are not candidates for surgery or radiotherapy, provided they lack EGFR, ALK, or ROS1 mutations.
• ESCC: The committee recommended extending use of Hetronifly to unresectable, locally advanced, recurrent, or metastatic ESCC in combination with fluoropyrimidine‑ and platinum‑based chemotherapy for the first‑line treatment of adults whose tumors express PD‑L1 with a combined positive score (CPS) of 5 or greater.

Hetronifly already holds EU authorization for extensive‑stage small cell lung cancer in combination with carboplatin and etoposide.

In the phase 3 ASTRUM-007 trial, which studied 551 patients with previously untreated, locally advanced or metastatic PD-L1-positive ESCC, adding serplulimab to standard cisplatin plus 5-fluorouracil chemotherapy improved both progression-free survival and overall survival compared with chemotherapy alone. The treatment also increased response rates and showed the greatest benefit in patients with higher PD-L1 expression (CPS, 10).

Hetronifly is administered once every 3 weeks by infusion. It is designated as an orphan medicine. 

Precision Therapy in RET-Driven Cancer 

Retsevmo, a highly selective RET inhibitor, received a positive opinion to expand its existing indications to include pediatric patients aged 2 years or older. The adult indications remain in place.

• Advanced RET fusion-positive thyroid cancer: The indication now applies to adults and pediatric patients aged 2 years or older with advanced RET fusion-positive thyroid cancer that is radioactive iodine-refractory (if radioactive iodine is appropriate).
• Advanced RET-mutant medullary thyroid cancer: The indication now applies to adults and pediatric patients aged 2 years or older with advanced RET-mutant medullary thyroid cancer.
• Advanced RET fusion-positive solid tumors: The indication now applies to adults and pediatric patients aged 2 years or older with advanced RET fusion-positive solid tumors when non-RET treatment options provide limited clinical benefit or have been exhausted. This replaces the earlier adults-only solid tumor indication. 

The advanced RET fusion-positive NSCLC indication remains unchanged for adults.

Retsevmo was approved under conditional marketing authorization and is available as capsules to be taken by mouth twice daily.

Clinical Monitoring and Implementation 

Clinicians are advised to utilize next-generation sequencing or polymerase chain reaction assay for biomarker-based patient selection prior to initiating these targeted therapies.

Hetronifly is associated with manageable but frequent grade 3 or higher events, including increased liver transaminase levels and hypertension. Other common side effects are hematologic toxicities such as neutropenia and anemia; metabolic abnormalities such as hypothyroidism, hyperglycemia, hyperlipidemia, hypoproteinemia, and hyponatremia; and reduced appetite, nausea, colitis, and alopecia. 

The most frequent toxicities of Retsevmo include pneumonia, headache, hypersensitivity, hypertension, abdominal pain, diarrhea, nausea, vomiting, fever, tiredness, bleeding, increased liver transaminase levels, increased creatinine level, and chylothorax.

Both medicines are subjected to additional monitoring. For all newly adopted extensions, detailed recommendations for use will be outlined in the updated Summary of Product Characteristics after final marketing authorization by the European Commission.