The DESTINY-PanTumor02 Phase II trial revealed high-level results for AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan), showcasing clinically meaningful progression-free survival (PFS) and overall survival (OS) in previously treated patients with multiple HER2-expressing advanced solid tumours. These positive outcomes mark the successful achievement of two secondary endpoints of the trial. In the primary analysis, Enhertu […]
The National Medical Products Administration (NMPA) of China has granted approval to AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for use as a monotherapy in adult patients with unresectable or metastatic HER2-low breast cancer. The approval applies to patients who have undergone prior systemic therapy in a metastatic setting or experienced disease recurrence within six […]
Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd, has announced the successful integration of the acquired biosimilars business from Viatris in over 70 countries in emerging markets, effective from July 1, 2023. The integration represents an increase in the scale and scope of Biocon Biologics’ operations. This transition comes after the $3.3 billion deal […]
Aurobindo Pharma has announced positive results from a Phase 3 clinical trial of its breast cancer biosimilar product, BP02 (Trastuzumab or biosimilar to Herceptin), developed by its subsidiary, Curateq Biologics. The clinical trial demonstrated that BP02 has a comparable efficacy and safety profile to Herceptin. The trial was a multi-center, randomized, double-blind study involving women […]
Daiichi Sankyo and AstraZeneca have received the approval of the European Union (EU) for their jointly developed Enhertu (trastuzumab deruxtecan) for the treatment of a type of breast cancer patients. Enhertu has been approved as a monotherapy for the treatment of adult patients having unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) breast […]
American biotechnology company Seagen (formerly Seattle Genetics) has received accelerated approval from the US Food and Drug Administration (FDA) for the company’s oral drug Tukysa (tucatinib) in combination with trastuzumab. Tukysa in combination with trastuzumab is indicated for the treatment of adult patients with RASwild-type, HER2-positive unresectable or metastatic colorectal cancer, which has advanced following […]
