FDA fast-tracks Roche lung cancer drug
pharmafile | February 2, 2015 | News story | Sales and Marketing | Cancer, FDA, MPDL3280A, Roche, bladder, lung, oncology, pdl1
Roche will be celebrating after its investigational cancer drug MPDL3280A has been fast-tracked by the FDA for the second time.
The immunotherapy was given an FDA breakthrough designation status last year in the bladder cancer setting, but has now scored in non-small cell lung cancer (NSCLC).
“Lung cancer is the leading cause of cancer death globally, and we are pleased the FDA has granted breakthrough designation for MPDL3280A in non-small cell lung cancer,’’ says Sandra Horning who is Roche’s chief medical officer and head of products.
MPDL3280A (also known as anti-PDL1 and RG7446) is an investigational monoclonal antibody designed to interfere with a protein called PD-L1.
It targets the protein expressed on tumours and tumour-infiltrating immune cells to prevent it from binding to PD-1 and B7.1 on the surface of white blood cells (T cells).
By doing so it may enable the activation of T cells that check for cellular abnormalities, thereby restoring their ability to effectively detect and attack tumours.
This FDA nod is based on early results of MPDL3280A in people whose NSCLC was characterised as PD-L1-positive by Roche in tests. Ongoing studies with the drug include lung and bladder cancer settings, and the Swiss firm plans to initiate Phase III trials in additional tumour types this year.
Roche has made significant headway into oncology and immunology which was recently reflected in its fourth quarter results, so this second fast-tracking will provide a further boost for the firm.
To add to that, its cancer portfolio was also bolstered by the announcement of a huge billion-dollar investment into cancer genomics research company Foundation Medicine last month.
Through the deal, Roche now owns between 52% and 56.3% of the genetic analysis company, and it is set to play a vital role in the firm’s future plans.
On the NSCLC good news, Horning adds: “We are committed to personalised healthcare, developing medicines like MPDL3280A with companion tests that may help us identify those who may be appropriate candidates for our medicines.”
Brett Wells
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