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FDA approves drug for bladder cancer, Reliance launches Biosimilar of Roche's Avastin
The U.S. Food and Drug Administration today approved Tecentriq (atezolizumab) to treat the most common type of bladder cancer, called urothelial carcinoma. This is the first product in its class (PD-1/PD-L1 inhibitors) approved to treat this type of cancer. The FDA granted the Tecentriq application breakthrough therapy designation,priority review status and accelerated approval for this indication.
Tecentriq is approved for the treatment of patients with locally advanced or metastatic urothelial carcinoma whose disease has worsened during or following platinum-containing chemotherapy, or within 12 months of receiving platinum-containing chemotherapy, either before (neoadjuvant) or after (adjuvant) surgical treatment. Urothelial carcinoma is the most common type of bladder cancer and occurs in the urinary tract system, involving the bladder and related organs.
The most common side effects of treatment with Tecentriq were fatigue, decreased appetite, nausea, urinary tract infection, fever (pyrexia) and constipation. Tecentriq also has the potential to cause infection and serious side effects that result from the immune system effect of Tecentriq (known as “immune-mediated side effects”). These severe immune-mediated side effects involve healthy organs, including the lung, colon and endocrine system.
Reliance Lifesciences has launched the world's first biosimilar, or copies of bevacizumab, a complex medicine used to treat at least six forms of advanced cancers. Reliance's product under the brand name Bevcirel is approved by the Indian regulator for use in cases of colorectal cancer. Roche is the innovator of bevacizumab and markets it globally as Avastin.
According to Economic Times Roche's Avastin of 100 mg strength is learnt to be sold at about Rs 29,500 while Reliance is likely to market its product at Rs 28,300 per injection. For the 400 mg variant, Avastin is available at about 1,08,000 and Reliance's drug is sold at 1,05,000 for each injection.