Perjeta becomes first approved drug for early breast cancer
pharmafile | October 1, 2013 | News story | Sales and Marketing | FDA, Herceptin, Perjeta, Roche
Roche’s Perjeta has become the first preoperative breast cancer drug to be authorised by the FDA after it was granted ‘accelerated approval’ by the regulator.
The designation is based on its use in combination with chemotherapy agent docetaxel and another Roche treatment, Herceptin (trastuzumab).
Perjeta (pertuzumab) is already approved in the US and Europe for the treatment of advanced HER2-positive breast cancer, an aggressive variation of the disease found in around 20% of cases.
Its expanded authorisation has led analysts to predict sales in the region of $2.7 billion by 2017 for Roche, according to Bloomberg.
This development may help soften the blow of blockbuster Herceptin’s looming patent expiry. The drug enjoyed sales of more than £4 billion in 2012, but drops off-patent in Europe next year and in 2019 in the US.
Director of the FDA’s Office of Hematology and Oncology Products Richard Pazdur, said: “We are seeing a significant shift in the treatment paradigm for early-stage breast cancer.”
He added: “By making effective therapies available to high-risk patients in the earliest disease setting, we may delay or prevent cancer recurrences.”
Accelerated approval status was established by the US regulator to allow drugs for serious conditions to be authorised on the basis of ongoing research.
Roche secured the designation for Perjeta after identifying its effectiveness in combination with Herceptin and docetaxol in a Phase II trial.
The study showed that cancer tissue shrank significantly under the treatment regimen, compared to other drug combinations.
Roche’s chief medical officer Hal Barron said: “Together with the FDA, we’ve charted new territory. We look forward to working with health authorities around the world to explore additional ways to bring promising medicines to patients more quickly.”
An estimated 1.4 million women were diagnosed with breast cancer globally in 2008, according to the International Agency for Research on Cancer. It is the most common form of cancer among women, accounting for nearly a quarter of all cases.
A Phase III trial of Perjeta, Herceptin and docetaxol in patients who have had previous surgery and are at risk of their cancer returning is underway, with data expected in 2016.
Hugh McCafferty
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