Anvisa approves Datroway for EGFR‑mutated advanced lung cancer
Brazil’s health regulator Anvisa granted a new indication for the antibody‑drug conjugate Datroway® (datopotamabe deruxtecana), produced by Daiichi Sankyo Brasil Farmacêutica Ltda. The approval, published on 27 July in the Diário Oficial da União, allows the drug to be used in adult patients with non‑small cell lung cancer (NSCLC) that is locally advanced or metastatic and carries an EGFR‑activating mutation. It is intended as a post‑line therapy for patients whose disease has progressed after prior EGFR‑targeted therapy and platinum‑based chemotherapy.
Datroway had previously been registered in Brazil for the treatment of triple‑negative breast cancer. NSCLC represents roughly 85 % of lung‑cancer cases, and lung cancer remains the leading cause of cancer death worldwide, highlighting the therapeutic need addressed by this new indication.
Entities: Agência Nacional de Vigilância Sanitária (Anvisa) · Brazil · Daiichi Sankyo Brasil Farmacêutica Ltda · Daiichi Sankyo Brasil Farmacêutica Ltda. · Datroway (datopotamabe deruxtecana) · Epidermal growth factor receptor (EGFR) gene · Non‑small cell lung cancer (NSCLC)
Claims
What the coverage asserts, and how well corroborated each claim is across sources.
- [● 20 SOURCES] Datroway's active ingredient is datopotamabe deruxtecana. (product description)
- [● 20 SOURCES] It is approved for patients who have progressed after EGFR‑targeted therapy and platinum‑based chemotherapy. (regulatory indication)
- [● 20 SOURCES] The drug is indicated for patients whose tumors have an EGFR‑activating mutation. (regulatory indication)
- [● 20 SOURCES] Datroway was already approved in Brazil for the treatment of triple‑negative breast cancer. (previous approval)
- [● 20 SOURCES] Non‑small cell lung cancer accounts for roughly 85 % of all lung‑cancer diagnoses. (epidemiology)
- [● 20 SOURCES] Lung cancer is the leading cause of cancer death worldwide. (global health data)
- [● 20 SOURCES] Anvisa approved a new indication for Datroway (datopotamabe deruxtecana) to treat adult patients with non‑small cell lung cancer. (Anvisa approval)
- [● 20 SOURCES] The approval was published on 27 July 2024 in the Diário Oficial da União. (official publication)