FDA Anounces Restricted use of Keytruda & Tecentriq Against Bladder Cancer

June 26, 2018  Source: FiercePharma 147

In the field of bladder cancer treatment, the five members of the PD-1/PD-L1 class namely Merck’s Keytruda, Roche’s Tecentriq, AstraZeneca’s Imfinzi, Bristol-Myers Squibb’s Opdivo and Pfizer’s Bavencio have claimed FDA drug approval.

But last month, the FDA restricted the use of Merck’s Keytruda and Roche’s Tecentriq among the patients with advanced or metastatic bladder cancer, who were not yet eligible for cisplatin-containing chemo.

Keytruda is now allowed only for the patients whose tumor expression levels of the biomarker PD-L1 meet a combined positive score of 10 or higher. Tecentriq can only be used where PD-L1 immune cells can cover only 5% or more of their tumor area.

Patients who are not eligible for platinum chemotherapy can still take either Keytruda or Tecentriq, irrespective of their PD-L1 status. Compared to platinum chemotherapy, patients with low PD-L1 status who were treated with these drugs had low survival chances. These sudden changes spell a huge setback for both companies.

The FDA’s review regarding these drugs is still ongoing. At present, the FDA recommends that cisplatin-ineligible patients with low PD-L1 levels can continue taking the drugs as directed by their healthcare professionals. The patients can consume them as long as they respond well.

By Ddu
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