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Merck KGaA, Threshold gain FDA fast-track review

Industry partners hope their new cancer drug will be approved by the end of the year

Merck KGaA pancreatic cancer

Merck KGaA and its research partner Threshold have been granted a speedy review for their new pancreatic cancer treatment evofosfamide.

The US regulator is assessing the medicine under its 'Fast Track' designation for the development of the drug (which was previously known as TH-302) in combination with Lilly's chemotherapy Gemzar (gemcitabine).

The two firms are seeking a US licence for the treatment of previously untreated patients with metastatic or locally advanced unresectable pancreatic cancer.

Evofosfamide is an investigational hypoxia-activated prodrug thought to be activated under severe tumor hypoxic conditions, a feature of many solid tumours.

It is currently in phase III trials, but both companies could see the drug approved within six months under the accelerated status. The treatment has already been fast-tracked for a separate licence in soft tissue sarcoma.

Luciano Rossetti, head of global research and development of Merck's biopharmaceutical business Merck Serono, said: “Merck is focused on discovering and developing innovative new therapeutic options for cancers that are particularly difficult to treat.

“Many patients with pancreatic cancer present with advanced, inoperable tumours, and there are limited treatment options currently available for them. The Fast Track designation for evofosfamide in pancreatic cancer […] will help to facilitate the timely development of this high-priority programme for Merck Serono.”

Barry Selick, CEO of Threshold Pharmaceuticals, added: “We are pleased that evofosfamide has been granted Fast Track status for the treatment of patients living with pancreatic cancer.

“Evofosfamide is currently being studied in patients with pancreatic cancer in the MAESTRO Phase III study, and based on current projections, we expect that the number of protocol-specified events for the trial may be reached in the second half of 2015, with the results of the primary efficacy analyses to be available shortly thereafter.”

The FDA established the Fast Track designation process to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions that demonstrate the potential to address unmet medical needs.

Pancreatic cancer is a relatively uncommon but lethal cancer, and is ranked as the twelfth most common cancer worldwide and the seventh most common cause of cancer-related death, accounting for 4% of all cancer deaths.

With 93–95% of patients dying from their disease within five years, pancreatic cancer also has a low survival rate. Surgery remains the most common intervention, with only a few chemotherapy agents available to treat the disease and one altered chemotherapy drug in the form of Celgene's Abraxane (nab-paclitaxel).

Article by
Ben Adams

13th May 2015

From: Research



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