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Roche's Tecentriq wins FDA OK as first-line treatment in bladder cancer (Regulatory)

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Roche’s checkpoint inhibitor Tecentriq, which won its initial approval as a treatment for bladder cancer, has now notched an approval to treat advanced bladder cancer, as the immunotherapy firmly establishes itself in the market with rivals Opdivo and Keytruda.

The FDA granted Tecentriq an accelerated approval as an initial treatment for patients with advanced bladder cancer who are not eligible for standard cisplatin chemotherapy, Roche’s Genentech announced Monday.

“Tecentriq was the first cancer immunotherapy approved by the FDA for people with advanced bladder cancer and has become a standard of care in those whose disease has progressed after receiving other medicines, either before or after surgery, or after their disease has spread,” Sandra Horning, chief medical officer and head of global product development for Roche, said in a statement.

It is the third approval in less than a year for Tecentriq, which was also the third PD-1/PD-L1 inhibitor approved by the FDA, behind Bristol-Myers Squibb’s Opdivo and Merck & Co.’s Keytruda, both of which were on the market more than a year before Tecentriq.

But Roche is in a good position with Tecentriq in bladder cancer, because it was the first approved as a second-line treatment in this area and is now the first to be designated as an initial treatment against the disease. Opdivo was approved in February as a follow-up treatment, and Merck is awaiting an FDA approval for Keytruda as a bladder cancer drug.

The beauty of immuno-oncology drugs is that they can work against a variety of cancers, and so the three companies have a host of trials going to test them as mono and combo therapies, even as they jockey for market share in the areas where they are approved, changing places in the horse race with each new approval or setback.

Opdivo, which had an approval as a second-line treatment in lung cancer, was dealt a serious blow last year when it failed in a trial as a first-line treatment against the disease. Then, this year, BMS dropped a trial of the drug in combination with its Yervoy as a first-line treatment. Merck’s Keytruda has won the coveted monotherapy approval in lung cancer, and Tecentriq has gotten approval as a second-line treatment.

Roche execs recently claimed to analysts that Tecentriq has been edging closer to Opdivo in that area, saying it has whittled 10 percentage points of Opdivo’s market share after launching in late October in lung cancer. That’s worrisome for Bristol-Myers, with 60% of Opdivo’s Q4 revenue coming from lung cancer sales.

Still, all three drugs are forecast to reach astronomical sales as they continue to win approvals. Although a lot may change over the next 5 years, EvaluatePharma and Chempetitive have projected Opdivo will reach $12.62 billion in sales by 2022, with Keytruda hitting $6.56 billion and Tecentriq $5.53 billion.

And new immuno-oncology drugs are still coming into the market. Last month, Pfizer and Merck KGaA won approval for their checkpoint inhibitor avelumab, branded as Bavencio, to target a rare, aggressive form of skin cancer, Merkel cell carcinoma.

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