Update for the Week Ending April 18, 2020

Regulatory Update
 
The FDA approved pemigatinib (Pemazyre, Incyte) on 4/17/2020 for the treatment of resistant advanced cholangiocarcinoma. 
 
The FDA approved tucatinib (Tukysa, Seattle Genetics) on 4/17/2020 the treatment of adults with advanced HER2-positive breast cancer who have received at least one prior line of therapy. WAC has been set at $18,500 per month; with a treatment duration of 6-months, a course of treatment will be $111,000 per patient. Due to restriction in social contact, a virtual launch for the drug is planned.
 
The FDA accepted the BLA for Regeneron Pharmaceuticals’ REGN-EB3 on 4/16/2020 for the treatment of Ebola virus infections and set a PDUFA date of 10/25/2020. REGN-EB3 was designated as both an Orphan Drug and Breakthrough Therapy.
 
The FDA granted Orphan Drug Designation to Ascendis Pharma’s lonapegsomatropin, as a treatment for growth hormone deficiency.
 
The FDA has granted Fast Track designations to Hutchison China MediTech (Chi-Med or HCM)’s surufatinib for the treatment of both advanced and progressive pancreatic neuroendocrine tumors and extra-pancreatic tumors.
 
Published Research Updates
 
In a 4-week, 245 patient, Phase II trial, treatment with SEP-363856 decreased the PANSS total score by 17.2 points compared a 9.7 point decrease with placebo in patients hospitalized with an acute exacerbation of schizophrenia.
 
In the 736 patient, Phase III, open-label, EAGLE trial, neither durvalumab monotherapy nor durvalumab plus tremelimumab improved overall survival compared to standard-of-care chemotherapy in patients with platinum-resistant head and neck squamous cell carcinoma.