FDA limits first-line bladder cancer labels for Keytruda, Tecentriq
- The Food and Drug Administration has announced that it will restrict the use of Merck & Co.'s Keytruda and Roche's Tecentriq in first-line bladder cancer to patients who express high levels of PD-L1.
- The label has been revised for each drug to include a requirement for testing for PD-L1 expression. Treatment continuation could be considered for patients responding to the drugs and who are cisplatin-ineligible.
- There has been no change to the label for patients with urothelial carcinoma who have disease progression during or following any platinum-containing chemotherapy, or within 12 months of neoadjuvant or adjuvant treatment.
Keytruda (pembrolizumab) and Tecentriq (atezolizumab) received accelerated first-line approval for use in previously-untreated patients with advanced urothelial carcinoma who were ineligible for cisplatin-containing chemotherapy. An upgrade to full approval was pending data from Merck's KEYNOTE-361 and Roche's IMvigor130 studies.
While the studies are still ongoing — KEYNOTE-361 is due to complete in June 2019 and IMvigor130 by the end of 2018 — the early outcomes have signaled a need for a label restriction. This follows an FDA warning in May 2018 that data monitoring committees had seen early signs of decreased survival in patients with tumors expressing low levels of PD-L1.
This will be a challenge for both companies but especially for Roche, which estimates that around 40% of its U.S. Tecentriq sales are in bladder cancer.
Roche and Merck, along with Bristol-Myers Squibb's Opdivo (nivolumab) are still fighting over the checkpoint inhibitor space.
Opdivo is the market leader, but Tecentriq got a boost last month when data showed it, in combination with chemotherapy, could increase survival in lung cancer patients. Some analysts predict the drug will edge past Opdivo in the U.S. metastatic non-small cell lung cancer market by 2019. However, Keytruda has the top spot in lung cancer, and also has positive survival data in combo with chemo.
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