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Roche’s PD-1 wins second FDA ‘breakthrough’ status

Will accelerate review of MPDL3280A in lung cancer
Roche headquarters

Roche has received a second 'breakthrough' designation from the US FDA for its promising cancer immunotherapy MPDL3280A.

The regulator will now speed up its review process for the drug as a treatment for non-small cell lung cancer (NSCLC) in people whose disease has progressed after treatment with a platinum-based chemotherapy.

The FDA has already deemed the drug a 'breakthrough' in metastatic bladder cancer. The status is reserved for new treatments for serious or life-threatening conditions that have already demonstrated “substantial improvement” over an existing therapy.

MPDL3280A is one of a new class of cancer treatment called anti-PD-L1 therapies, a subset of the anti-PD-1 class.

These drugs work by targeting PD-L1, a protein expressed on tumour cells which can disrupt the ability of a person's immune system to fight the disease. By targeting PD-L1 MPDL3280A and other drugs of its kind can restore the ability of T cells to fight tumour cells.

Roche has developed MPDL3280A to also interact with the protein B7.1, which again plays a role in the immune system's ability to fight cancer.

The FDA's breakthrough designation for the drug is reserved for patients with NSCLC that has been diagnosed as PD-L1-positive by a test being developed by Roche, although the company also has trials in place to assess the drug regardless of the tumour status.

Acknowledging the rising prominence of personalised medicine, the FDA says that patients with an EGFR mutation-positive or ALK-positive tumour should also have had a suitable therapy to target the specific genetic mutation.

Several anti-PD-1 therapies have already hit the US market, although Merck & Co's Keytruda (pembrolizumab) and BMS' PD-1 blocker Opdivo (nivolumab) are available as treatments for the skin cancer melanoma rather than lung or bladder cancer.

Further studies are in underway investigating the use of these drugs in other oncology indications, however, including lung cancer and bladder cancer, heralding a competitive market for immunotherapies.

AstraZeneca is also making headway in the area with its anti-PD-L1 MEDI4736 in advanced trials in lung cancer.


Article by
Thomas Meek

3rd February 2015

From: Sales



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