Regulatory Index News: 11/12/2017

Welcome to your Monday Regulatory Index News digest. There are plenty of developments in the industry so take a read here.

FDA guidance for 3D-printed drugs

The US FDA have released guidance for the use of 3D printing in healthcare manufacturing, focusing on medical devices. This is due to the acknowledgment that 3D printing may prove a great disruptive technology for drug development. One 3D printed drug, Spritam, has already been approved for use and exponential growth of research in this innovative technology is evident. It has been speculated by FDA commissioner, Scott Gottlieb, that the near future may provide 3D printed skin grafts for burn patients whilst it may also be used to eventually develop replacement organs. The new guidance offers guidelines and suggestions for what medical manufacturers must consider when developing 3D printed products but has been deemed a “leap-frog” guidance which will develop as a greater understanding of 3D printing in the healthcare industry is achieved. Please click here if you would like to read more on this story from a BioPharmaDIVE article.

Eisai’s Lenvima turnaround NICE approval for kidney cancer

After turning the drug down in draft guidance in August, the UK price regulators have approved its use in adult patients with kidney cancer. It will be used in combination with chemotherapy in patients which have had previous VEGF-targeted therapy and only if the patient’s Eastern Cooperative Oncology Group performance status score is 0 or 1. NICE however did not approve the use of Lenvima in thyroid cancer, via the Cancer Drugs Fund (CDF), even though the data previously presented extended overall survival compared to placebo. This is due to the large price-tag of the drug which costs around £35,000 per year and is too expensive for approval. If this story interests you, click here for further information from FiercePharma.

Full US approval for Avastin in glioblastoma

Roche have announced a full US approval for their glioblastoma treatment, Avastin, for treatment of those patients which have progressed following prior therapy. This leaves the drug approved for 9 distinct uses in the US covering 6 different cancer types. The basis of the new approval was on the totality of evidence for Avastin in glioblastoma which included data from the Phase III EORTC 26101 trial that showed combination with lomustine increased the time to disease progression and death when compared to chemotherapy alone. The treatment also showed the reduced need for corticosteroids when compared to the control arm which is also considered an important goal for glioblastoma treatment. Please click here to read more from a PharmaTimes article. 



Max Lymbery

Date Published

11th December 2017

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