- Roche will withdraw its cancer immunotherapy Tecentriq for use treating people with bladder cancer whose disease has progressed after chemotherapy. The decision was disclosed Monday as part of a Food and Drug Administration review of drugs that won accelerated approval based on small studies that were later contradicted by larger trials.
- The FDA cleared Tecentriq for this use in 2016, the drug's first-ever approval, based on data showing it shrank tumors and helped patients achieve remission in a trial run without a placebo comparison. A later trial required by the agency to confirm Tecentriq's benefit failed to show treatment helped patients live longer.
- Roche's decision follows withdrawals of AstraZeneca's similarly acting drug Imfinzi in bladder cancer as well as Merck & Co.'s Keytruda and Bristol Myers Squibb's Opdivo in a type of lung cancer for similar reasons. The FDA uses accelerated approvals to speed treatments for serious diseases, but until now its track record in pushing for the withdrawal of drugs that failed confirmatory studies has been mixed.
Tecentriq was the fourth drug approved that worked by blocking a "checkpoint" protein that helps tumor cells evade destruction by the immune system. The first three, Keytruda and Bristol Myers Squibb's Opdivo and Yervoy, were first targeted at melanoma, a disease known to resist immune response, so Roche's strategy of going after bladder cancer instead represented a different direction.
The drug has since gained approval in melanoma and lung, breast, and liver cancer, none of which are affected by Monday's decision. In 2020, Tecentriq had sales of 2.7 billion Swiss francs, or nearly $3 billion.
When the FDA approved Tecentriq, the agency required Roche conduct a trial comparing Tecentriq to chemotherapy in second-line bladder cancer. That trial, called IMVigor211, failed to show Roche's drug helped patients live longer.
The FDA also agreed to another confirmatory trial called IMVigor130, which pairs Tecentriq with chemotherapy, to support full approval. That study of newly diagnosed patients showed the combination therapy helped newly diagnosed patients live significantly longer without disease progression than chemotherapy alone — 8.2 months versus 6.3 months.
Roche said a factor in its decision to withdraw, however, is the "emergence of new treatment options." Keytruda has since been shown to extend survival in bladder cancer patients who have progressed after chemotherapy, and it's also used in newly diagnosed patients who can't receive chemotherapy.
The FDA's Oncology Center of Excellence, a key review division within the agency, is engaged in an "industry-wide evaluation" of cancer-related accelerated approvals, a spokesperson confirmed to BioPharma Dive. The agency also "regularly monitors the status of drugs approved through the accelerated approval pathway."
The accelerated approval pathway has proven controversial because follow-up studies often aren't completed or are slow to deliver data. Even when the follow-up data are negative, drugmakers don't always withdraw drugs quickly. IMVigor211's negative results, for example, came nearly four years ago.