ICER requests public comment on two draft scoping documents: treatments for high-risk prostate cancer and amyloidosis

ICER

12 March 2018 - The ICER has posted two draft scoping documents outlining planned reviews of 1) three anti-androgen therapies for certain types of high risk prostate cancer, and 2) two therapies for hereditary transthyretin-related amyloidosis. 

The scoping documents will be open to public comment for three weeks until April 2, 2018 at 5pm ET.

ICER’s report on treatments for high risk, non-metastatic, castration resistant prostate cancer is expected to include three anti-androgen therapies: enzalutamide (Xtandi, Astellas and Pfizer), abiraterone acetate (Zytiga, Janssen), and apalutamide (Erleada, Janssen).

The review of therapies for hATTR amyloidosis is expected to include inotersen (Ionis Pharmaceuticals, Inc.), an antisense oligonucleotide that interferes with transthyretin production in the liver, and patisiran (Alnylam Pharmaceuticals), which inhibits transthyretin through an RNA interference pathway. Both therapies are currently under review by the FDA, with approval decisions expected in July and August of 2018, respectively.

Read ICER announcement

Michael Wonder

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Michael Wonder