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Keytruda claims first blood cancer OK from FDA

Merck & Co wins US approval for its haematological cancer treatment

Merck & Co

Merck & Co has won FDA clearance for its PD-1 inhibitor Keytruda in classical Hodgkin lymphoma (cHL), the first green light for the drug in a haematological cancer.

The US regulator gave a conditional approval to Keytruda (pembrolizumab) for cHL patients who have relapsed after three or more prior lines of therapy on the back of tumour response data, which will be upgraded to a full approval if data from ongoing trials are positive.

In the KEYNOTE-087 trial, Keytruda achieved an overall response rate of 69%, with 22% going into complete remission and 47% into partial remission.

While cHL is considered one of the most treatable types of cancer with generally high five-year survival rates, a subset of patients who are not cured with existing treatments have limited options.

"This approval is an important step forward in treating these patients, who are generally young and have a particularly poor prognosis, and gives us the opportunity to help patients in their fight against this devastating disease," said Craig Moskowitz, clinical director of the division of haematologic oncology, Memorial Sloan Kettering Cancer Centre in the US.

The new indication is the fourth for Keytruda after melanoma, non-small cell lung cancer and head and neck cancer. It's another leg-up for Merck in its rivalry with Bristol-Myers Squibb (BMS), which still leads the market but has suffered a series of setbacks with its PD-1 blocker Opdivo (nivolumab)

Opdivo has already been approved in the US and Europe for cHL in patients who have previously been treated with as stem cell transplantation and Takeda's antibody drug conjugate Adcetris (brentuximab vedotin), so Merck is playing catch-up in this indication.

However, Merck is making much of its FDA label saying Keytruda is "the only anti-PD-1 therapy approved for the treatment of patients with difficult-to-treat cHL regardless of prior stem cell transplantation or use of brentuximab vedotin."

The impact of that label difference remains to be seen, but in any event Opdivo's dominant position was undermined when it failed to show efficacy in a first-line NSCLC last year, effectively handing over that segment to Keytruda with a knock-on impact in second-line therapy.

BMS had hoped to set things straight with a swift filing of the combination of Opdivo and its Yervoy (ipilimumab) checkpoint inhibitor for first-line NSCLC, but said in January it would have to delay those plans.  It is now in the midst of restructuring in its R&D operations, including a change in leadership with chief scientific officer Francis Cuss leaving this week to be replaced by Thomas Lynch.

Article by
Phil Taylor

15th March 2017

From: Regulatory

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