The European Medicines Agency (EMA) has recommended granting marketing authorization for orphan medicine Hetronifly (serplulimab, Henlius Europe) to treat extensive stage small cell lung cancer (ES-SCLC).

The cancer is considered to be extensive if it has spread widely throughout the lung, to the other lung, or to other parts of the body. According to the American Cancer Society, around two out of three patients with SCLC have reached the extensive stage at first diagnosis.

The active substance of Hetronifly is serplulimab, an antineoplastic monoclonal antibody. It works by blocking the binding of PD-1 to PD-L1 and PD-L2 to increase the effectiveness of T-cell responses, including anti-tumor responses.

Hetronifly Plus Chemotherapy

The EMA Committee for Medicinal Products for Human Use (CHMP) accepted positive evidence from a study of adults with ES-SCLC who had not been treated with systemic therapy that Hetronifly, in combination with carboplatin and etoposide, led to improved overall survival and progression-free survival compared with patients treated with the chemotherapy drugs alone.

Research published in JAMA in 2022 of 585 patients with ES-SCLC who had not previously received systemic therapy concluded that serplulimab plus chemotherapy, compared with placebo plus chemotherapy, significantly improved overall survival (15.4 vs 10.9 months, respectively; hazard ratio for death, 0.63).

According to the CHMP, the most common side effects of Hetronifly combined with carboplatin and etoposide are neutropenia, leukopenia, anemia, thrombocytopenia, alopecia, nausea, hyperlipidemia, decreased appetite, hypoproteinemia, hyponatremia, hypothyroidism, and hyperthyroidism.

Hetronifly should be prescribed and supervised by doctors experienced in the treatment of cancer, the committee said.

Hetronifly will be available as a 10-mg/mL concentrate for solution for infusion.

The EMA said it would be reviewing the latest information to decide whether to maintain the status of Hetronifly as an orphan medicine.

A final decision on whether to grant marketing authorization will be taken by the European Commission.