The week in industry: NICE rejects KEYTRUDA® as treatment for head and neck cancer

This week: an advanced prostate cancer treatment granted US FDA priority review and a partnership announced that will leverage AI and computational biophysics to develop novel cancer therapies.

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Jan 16, 2020
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This week's industry news: 

NICE rejects KEYTRUDA® for treatment of head and neck cancer
Advanced prostate cancer treatment granted priority review
Partnership will leverage AI and computational biophysics to develop novel cancer therapies


NICE rejects KEYTRUDA® as treatment for head and neck cancer

This week, NICE released draft guidance on their recommendation of KEYTRUDA® (pembrolizumab), in which they state they need further analyses from Merck (NJ, USA) before they can stand to recommend it as a first-line treatment for patients with advanced head and neck cancer. Keytruda, has already been approved as by the US FDA and the EMA as an anti-PD-1 treatment option for these patients, however NICE does not recommend its approval for use in the UK. The Institute of Cancer Research (ICR; London, UK), who led KEYNOTE-048 – the key clinical trial for the drug, have responded, stating this decision by NICE must be reassessed.

“The decision by NICE brings the UK further out of step with clinical practice in the rest of the world, where cancers of the mouth are treated in the same way as other head and neck cancers,” commented, Kevin Harrington (Professor at ICR). “There is clear evidence that pembrolizumab has survival benefits for patients with head and neck cancer, and it is also a much kinder treatment than intensive chemotherapy.”

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Advanced prostate cancer treatment granted priority review

RUBRACA® (rucaparib) has been granted priority review status by the US FDA. The drug has been developed by Clovis Oncology (CO, USA) as a monotherapy treatment indicated for the treatment of adults with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer. Drug review by the FDA typically takes 10 months, but with this approval, this will be reduced to 6 months, to ensure the necessary patient groups gain access to the drug in a timely fashion.

“Recently presented data suggests that Rubraca may play a meaningful role in the treatment of patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer, and this filing represents an important milestone for Clovis as it brings us one step closer to potentially making this valuable therapy available,” commented Patrick J. Mahaffy, President and CEO of Clovis Oncology. “We are encouraged by the FDA’s decision to grant priority review to the Rubraca application, which focuses on eligible patients with advanced prostate cancer, for whom new treatment options are very much needed.”

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Partnership will leverage AI and computational biophysics to develop novel cancer therapies

AUM Biosciences (Singapore, Singapore) and Cyclica (ON, Canada) have announced they will be entering into a partnership to advance the development of novel cancer therapies. Under the terms of the agreement, AUM will combine their drug discovery and development expertise with Cyclica’s integrated AI-augmented and structure-based platform, to design novel cancer therapies with greater precision and speed.

“The ability to delve deeper into complex medical outcomes enhances the potential for discovery and assessment of novel molecules while in the development stage, which reduces the risk of failure and expedites the process,” commented Vishal Doshi, CEO of AUM. “We are excited about this partnership with Cyclica, which will help us discover the undiscovered to address the needs of patients in Asia.”

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