Regulatory Index News: 05/06/2018

Welcome to your Regulatory Index News digest for today. Take a look here for reports of a new US approval and details of two ongoing cancer combo trials

Lilly and Incyte announces US approval for Olumiant in rheumatoid arthritis

Eli Lilly and Incyte’s once-daily JAK inhibitor Olumiant (baricitinib) has received approval from the FDA for rheumatoid arthritis (RA). This follows a US Food and Drug Administration’s Arthritis Advisory Committee (AAC) recommendation early in 2018 that adult patients with moderately-to-severely active RA be prescribed a 2 mg dose of the drug when inadequate response or intolerance to methotrexate is found. Data from the RA-BEACON study involving 527 patients, submitted in support of the approval, showed that those treated with Olumiant had significantly higher ACR20 response rates (49%) when compared with patients receiving placebo (27%) at Week 12. Although the AAC supported the efficacy of the Olumiant 4 mg dose, the safety and benefit-risk profiles prevented them from recommending its approval for use. Lilly anticipates the launch of the drug in the US by the end of the second quarter of 2018. Please click here to read more on this from a PharmaTimes article.


Both adults and children to be included in a new AZ/Merck cancer combo trial

AstraZeneca and Merck are launching a Phase I trial across the UK and EU to investigate the effectiveness of their selumetinib product in combination with dexamethasone as a treatment for leukaemia in both adults and children. The SeluDex trial, as it is called, is being launched by Cancer Research UK and the Experimental Cancer Medicine Centres (ECMC) Network as a joint initiative and is intended to include both adults and children with relapsed or refactory acute lymphoblastic leukaemia (ALL) and with a gene mutation involved in the RAS pathway. In addition to determining the optimal dose of selumetinib in combination with dexamethasone, the study also intends to collect preliminary data on the effectiveness of the two drugs in combination. Please click here to read more on this from a PharmaTimes article.

AbbVie’s blood cancer combo Phase 2 trial starts well

High response rates have been seen in AbbVie's Phase 2 CAPTIVATE study of patients suffering from chronic lymphocytic leukemia or small lymphocytic lymphoma. CAPTIVATE combines AbbVie's two blood cancer drugs Imbruvica and Venclexta, with approximately 90% of the first 14 patients that completed a full treatment (12 cycles) of the combination having no detectable cancer cells. The data was presented recently at the American Society of Clinical Oncology, where it was also shown that out of the first 30 patients enrolled, 77% showed no detectable cancer cells after six treatment cycles. And, according to the study sponsor AbbVie, the investigators have not reported any dose-limiting toxicities in those patients that completed the full 12 cycle treatment. Please click here to read more on this from a BioPharmaDive article.



Lorna Osborn

Date Published

05th June 2018

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