Megan Thomas spoke to Leon Moore, Head of Global Brand Strategy & Marketing at Astellas, about how the company’s new Asset Maximization Teams are fostering collaboration and improving outcomes. MT: Astellas recently implemented a new structure, for its research, development and commercial teams to get innovative medicines to patients, faster. Read More
The US Food and Drug Administration (FDA) has approved Vyloy (zolbetuximab-clzb) for locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma. It is approved in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults whose tumours are claudin… Read More
The European Commission has granted marketing authorisation for antibody-drug conjugate (ADC) Padcev (enfortumab vedotin) in combination with PD-1 inhibitor Keytruda (pembrolizumab) for urothelial cancer. It is approved for the first-line treatment of adult patients with unresectable or metastatic cancer, who are eligible for platinum-containing chemotherapy. The approval is based on… Read More
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has licensed Astellas’ Vyloy (zolbetuximab), an anti-claudin 18.2 (CLDN18.2) monoclonal antibody. It is licensed in combination with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric… Read More
Japan’s Ministry of Health, Labour and Welfare (MHLW) has approved Vyloy (zolbetuximab), an anti-claudin 18.2 (CLDN18.2) monoclonal antibody for patients with CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer. Vyloy is the first and only CLDN18.2-targeted therapy approved by any regulatory agency in the world. Gastric cancer is the third… Read More
The US Food and Drug Administration (FDA) has granted orphan drug and paediatric exclusivity to Cresemba (isavuconazonium sulfate) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in paediatric patients. In December 2023, Cresemba for injection was approved for paediatric patients one year of age and older and… Read More
Astellas-owned Xyphos Biosciences and Kelonia Therapeutics have entered into a research collaboration and license agreement to develop novel immuno-oncology therapeutics. Under the terms of the agreement, the companies plan to combine Kelonia’s iGPS with Xyphos’ ACCEL technology to develop in vivo CAR-T cell therapies targeting up to two programmes. Kevin… Read More
Astellas has submitted a supplemental new drug application (sNDA) in Japan for Padcev (enfortumab vedotin (genetical recombination)) with Keytruda (pembrolizumab (genetical recombination)) for the first-line treatment of advanced bladder cancer. If approved, it would be the first combination in Japan to offer an alternative to chemotherapy, the current standard of… Read More
The US Food and Drug Administration (FDA) has approved antibody-drug conjugate (ADC) enfortumab vedotin-ejfv (Padcev) in combination with pembrolizumab (Keytruda) for patients with locally advanced or metastatic urothelial cancer (la/mUC). The approval is based on clinical data which found that Padcev plus pembrolizumab nearly doubled median overall survival compared to… Read More
Astellas’ Veoza (fezolinetant) will soon be available to some women in the UK suffering from vasomotor symptoms (VMS) associated with menopause following approval by the Medicines and Healthcare Regulatory Agency (MHRA). Despite VMS, or hot flushes, being a common symptom of menopause, until now, hormone replacement therapy (HRT) was the… Read More
The US Food and Drug Administration (FDA) has approved Izervay (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The new complement C5 inhibitor is the only approved GA treatment with a statistically significant reduction in the rate of GA progression at… Read More
Astellas Pharma will invest $50 million into Poseida Therapeutics to secure the rights to the company’s cancer CAR-T cell therapy for solid tumours, which is currently in Phase I trials. The total $50 million will include $25 million to acquire 8,333,333 shares of common stock of Poseida and a one-time… Read More
The European Medicines Agency (EMA) has accepted for regulatory review Astellas Pharma’s marketing authorisation application (MAA) for zolbetuximab, an investigational Claudin 18.2 (CLDN18.2)-targeted monoclonal antibody. The application is for authorisation as a first-line treatment of patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose… Read More
Astellas Pharma and MIMETAS, which specialises in human disease modelling, have entered a strategic partnership to develop treatments for cancer. The companies will use MIMETAS’ tumour models to support the next generation of immuno-oncological therapies. “We are excited to make this next step in… Read More
