Merck's Keytruda gets Singapore HSA nod, aiding regional prospects

Keytruda has gotten approval from Singapore's Health Sciences Authority (HSA) for the treatment of advanced melanoma, marking the first such nod in Southeast Asia and among a handful of countries in the region.

Australia, which reimburses for the treatment, South Korea, Taiwan and Macao are the only other countries that have approved the drug known as pembrolizumab, though in October Japan placed Keytruda on a fast-track approval process.

MSD, as Merck ($MRK) is known outside of the United States and Canada, said at a press event that the approval is for patients that show disease progression following therapy with ipilimumab.

The approval, which HSA noted on its website in late October, should see a stream of patients from nearby countries seeking treatment in Singapore, a financial and medical hub for the region.

Associate Professor Richard Quek, senior consultant and deputy head at the National Cancer Centre of Singapore, said at the press event that so far only a handful of patients are on the treatment on a specialized referral system, but that is expected to widen rapidly in the coming year.

Quek however did cite cost as a barrier, an issue that cropped up in New Zealand this month when Pharmac was criticized for not approving Keytruda for reimbursement.

The agency cited the per-patient cost of $42,470 to $132,710 and a refusal by MSD to lower the price to what Pharmac considered more reasonable. Pharmac experts also said data showed most patients would not see a change in their tumors or a longer period of survival.

However, Alex Menzies, senior research fellow at the Melanoma Institute of Australia, Royal North Shore Hospital and the University of Sydney, said the evidence in Australia was solid.

He told the press conference at Singapore General Hospital that the drug has shown "impressive" results among patients in Australia which has among the highest concentration per population in the world.

"Keytruda is highly effective for patients with advanced melanoma and far less toxic than earlier chemotherapy treatments," he said.

The effectiveness of the drug was also recently highlighted in the treatment of former U.S. President Jimmy Carter who was declared free of cancer after receiving Keytruda and radiation therapy for his metastasized melanoma.

- here's the MSD release (PDF)
- and the HSA notice from October

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