Merck issued the following announcement on Jan. 3.
Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that KEYTRUDA, Merck’s anti-PD-1 therapy, has simultaneously received five new approvals from the Japan Pharmaceuticals and Medical Devices Agency (PMDA), including three expanded uses in advanced non-small lung cancer (NSCLC), one in melanoma, as well as a new indication in advanced microsatellite instability-high (MSI-H) tumors. The following new approvals were all granted priority review by the PMDA:
KEYTRUDA in combination with pemetrexed and platinum-based chemotherapy (cisplatin or carboplatin) for the first-line treatment of unresectable, advanced/recurrent nonsquamous NSCLC regardless of PD-L1 expression (based on results of the Phase 3 trial KEYNOTE-189);
KEYTRUDA in combination with carboplatin and paclitaxel or nab-paclitaxel for the first-line treatment of unresectable, advanced/recurrent squamous NSCLC regardless of PD-L1 expression (based on results of the Phase 3 trial KEYNOTE-407);
KEYTRUDA monotherapy in the first-line treatment of PD-L1-positive (Tumor Proportion Score [TPS] ≥1%) unresectable, advanced/recurrent NSCLC (based on results of the Phase 3 trial KEYNOTE-042);
KEYTRUDA monotherapy as adjuvant therapy for melanoma (based on results of the Phase 3 trial EORTC1325/KEYNOTE-054, a study sponsored by Merck and conducted in collaboration with the European Organisation for Research and Treatment of Cancer [EORTC]); and
KEYTRUDA monotherapy for the treatment of advanced/recurrent MSI-H solid tumors that have progressed after chemotherapy (only if refractory or intolerant to standard therapies), based on results of two Phase 2 trials, KEYNOTE-164 and KEYNOTE-158. A companion diagnostic to detect MSI-H, the MSI test kit FALCO by FALCO Biosystems Ltd., has also been approved.
“These five simultaneous approvals of KEYTRUDA in Japan represent a significant achievement that involved extensive collaboration with the Japan Pharmaceuticals and Medical Devices Agency,” said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. “We appreciate the Agency’s efforts to expedite availability of this important medicine to more patients living with cancer in Japan.”
In addition to the adjuvant therapy approval, dosage and administration for all patients with melanoma has been changed from intravenous infusion of 2 mg/kg (body weight) over 30 minutes at a three-week interval to intravenous infusion of the fixed dose of 200 mg over 30 minutes at a three-week interval. Previously, KEYTRUDA was approved in Japan for the treatment of curatively unresectable melanoma; PD-L1-positive unresectable, advanced or recurrent NSCLC (TPS≥1% in second-line setting; TPS≥50% in first-line setting); relapsed or refractory classical Hodgkin lymphoma; and curatively unresectable urothelial carcinoma that progressed after chemotherapy. KEYTRUDA is marketed by MSD in Japan and is co-promoted with Taiho Pharmaceutical Co., Ltd.
“KEYTRUDA was first approved in Japan almost two years ago and has rapidly become an important therapy in a number of different types of cancer,” said Jannie Oosthuizen, managing director of MSD in Japan. “Cancer is the leading cause of death in Japan, so with these new approvals, we are proud to bring renewed hope to even more people with cancer in Japan and their families.”
In Japan, it is estimated that in 2018, there would be more than 850,000 new cancer diagnoses and over 400,000 deaths, making cancer the leading cause of death. Though lung cancer is the second most commonly diagnosed cancer in Japan (after colorectal cancer), it is the leading cause of death from cancer in the country with approximately 74,000 deaths each year. Lung cancer is categorized by histology into small cell lung cancer and NSCLC (adenocarcinoma, squamous cell carcinoma, large cell lung cancer). Non-small cell lung cancer accounts for about 85 percent of all lung cancers.
Melanoma, the most serious type of skin cancer, is characterized by the uncontrolled growth of pigment-producing cells. It has been reported that in Japan, about 4,000 people develop the disease and 600 people die from the disease each year. In stage III melanoma, cancer has spread to the lymph nodes in the region. After surgically resecting tumors and affected lymph nodes in the primary region, most cases are recurrent and become metastatic.
Microsatellite instability (or MSI) is defined by the National Cancer Institute as a change that occurs in the DNA of certain cells (such as tumor cells) in which the number of repeats of microsatellites (short, repeated sequences of DNA) is different from the number of repeats that was in the DNA when it was inherited. The cause of MSI may be a defect in the ability to repair mistakes made when DNA is copied in the cell. This defect is also referred to as mismatch repair deficient (dMMR).
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