Astellas Prostate Cancer Drug Xtandi Receives MHRA Approval

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Recently, the British Medicines and Health Products Administration (MHRA) approved Astellas prostate cancer drug Xtandi (enzalutamide, enzalutamide) for the treatment of adult male patients with metastatic hormone-sensitive prostate cancer (mHSPC).

With this approval, Xtandi has become the only oral therapy approved by the MHRA to treat 3 types of advanced prostate cancer, including: high-risk non-metastatic and metastatic castration-resistant prostate cancer (nmCRPC, mCRPC) and mHSPC.

Xtandi was first developed by Medivation in the United States and licensed to Astellas outside the United States.

mHSPC refers to prostate cancer that has metastasized, but still responds to androgen deprivation therapy (ADT).

The approval is based on the results of the Phase 3 ARCHS trial.

On the same day, the National Institute of Health and Care Excellence (NICE) issued a final guideline, rejecting the use of Pfizer Vyndaqel (tafamidis, 61mg) into the British National Health Service (NHS) for the treatment of rare heart diseases— -Transthyretin amyloid cardiomyopathy (ATTR-CM).

In the UK, approximately 800 people suffer from ATTR-CM, a rare, underdiagnosed, life-threatening disease characterized by the abnormal deposition of a misfolded protein called amyloid in the heart .

NICE pointed out that Vyndaqel’s cost-benefit estimates are higher than NHS resources generally consider acceptable standards.

But at the same time, NICE is "still keen" to ensure that ATTR-CM patients get Vyndaqel.

Vyndaqel (tafamidis, 61mg) was approved by the European Union in February 2020, becoming the first drug to treat ATTR-CM.

Reference source: FDA unexpectedly grounds a gene therapy for a rare heart disease