Recently, the U.S. FDA approved Roche Holding AG’s drug Zelboraf, designed for the treatment of a rare form of blood cancer – the Erdheim-Chester disease (ECD). The approval of the medicine from the food & drug regulating authority for treating the disease is first of its kind in the country. The FDA has reported that nearly 600 to 700 patients across the globe suffer from Erdheim-Chester ailment and approximately 54% of them suffer from ECD with BRAF V600 mutation.
Medical sources claim that the approval was based on the findings of phase 2 VE-BASKET research study, that included clinical tests of the drug on twenty-two patients suffering from Erdheim-Chester disease with BRAF V 600 mutation. The trials were conducted to determine the total or partial shrinking in cancer tumor size after the drug intake. Researchers apparently have also found that half of the patients had experienced a partial reduction in tumor and 1 patient from the other half experiencing a total shrink.
According to reliable sources, Zelboraf is already approved by the FDA for treating melanoma, a critical type of skin cancer occurring in the patients whose cancer tissues undergo BRAF V600 mutation. The U.S. food authority has also taken yet another proactive measure towards cancer cure by approving Roche’s medicine Alecensa, which is used to treat patients with a rare type of non-small cell lung cancer caused due to mutations in the ALK gene.
It has been found that the non-small cell lung cancer type is diagnosed in nearly eighty-five percent of patients suffering from lung cancer across the U.S. The approval of drugs such as Alecensa to treat the specific non-small cell lung cancer form will prove a boon in disguise for the lung cancer patients not only in the U.S., but also across the globe, claim industry experts.
For the record, earlier, Roche’s Alecensa had also received the approval from the U.S. drug regulator for treating the lung cancer patients after findings revealed that Pfizer’s drug Xalkori had proved to be ineffective against the disease.
