By Rajaneesh K Gopinath
The Fruquintinib capsules were commercially launched two days ago, after making headlines as the first home grown monotherapy developed for metastatic colorectal cancer (CRC) approved in China. This month also saw the drug coming under a cloud following an unsuccessful clinical trial in treating advanced NSCLC.
In what could be considered a significant milestone for Hutchinson China Meditech Limited, the company on November 26th, announced the commercial launch of their novel anti-VEGF inhibitor. The Fruquintinib capsules is to be marketed in China with the brand name Elunate in collaboration with Eli Lilly and company. Last September, the drug grabbed the world’s attention by becoming the first China-discovered and developed treatment for CRC (http://en.geneonline.news/2018/09/11/fruquintinib-becomes-the-first-homegrown-oncology-drug-approved-in-china-for-major-indication/). It’s approval following the success of the Phase III randomized clinical trial, FRESCO was described as a major achievement for the company by its chairman Simon To.
He was equally excited about the commercial launch calling it a major milestone for Chi-Med. “We are very proud to have brought Fruquintinib from its initial discovery through to its first sale, and now look forward to seeing patients in China benefit from this important new therapy.” he said. “This achievement reinforces Chi-Med’s position as a fast emerging biotech company, and illustrates China’s capability to emerge as an important global force in oncology innovation.” he added with unbridled enthusiasm.
The unsuccessful Phase III FALUCA Trial
Fruquintinib was also tested in various other development programs such as solid tumors and advanced gastric adenocarcinoma among others. One such was the randomized, placebo-controlled, Phase III FALUCA study involving patients with advanced non-squamous NSCLC who have failed two lines of systemic chemotherapy. Although statistically significant improvement were observed in all the secondary endpoints including progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR) and duration of response (DoR), Fruquintinib failed to meet it’s primary endpoint which is significant improvement in overall survival (OS) as compared to the placebo. This led to the sudden fall of nearly 21% of it’s market shares.
In summary, there are reasons for both concern and celebration for Chi-Med. In the coming months, the medical and pharma community will have a close watch on the performance of Fruquintinib in other trials such as FRUTIGA involving combination therapies.
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