MHRA accept Roche’s bladder cancer immunotherapy drug for Early Access to Medicines Scheme
Roche’s Tecentriq has scored another positive opinion. The Medicines and Healthcare products Regulatory Agency (MHRA) has recently accepted the immunotherapy drug into the Early Access to Medicines Scheme (EAMS) for the treatment advanced bladder cancer.
The decision means that patients suffering from bladder cancer could have access to the drug while it awaits decision from the UK and Europe’s regulatory bodies. The drug scored approval from the FDA to treat locally advanced or metastatic urothelial carcinoma (mUc), making it the first and only immunotherapy drug to be cleared for the indication in the US.
The FDA also gave clearance to the drug in October for the treatment of metastatic non-small cell lung cancer, and has awarded it Priority Review for mUC treatment in patients for whom cisplatin chemotherapy is not suitable and who have either not received first-line treatment or have disease progression at least 12 months after receiving chemotherapy before or after surgery.
The decision came as even more good news for Roche who earlier this week saw its drug Actemra granted Priority Review designation from the FDA to treat giant cell arteritis.