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Weekly Drug News Round-Up: October 28, 2015

Merrimack’s Onivyde Approved for Metastatic Pancreatic Cancer

In 2015, there will be over 40,000 new cases of pancreatic cancer diagnosed and a similar number of deaths Read More...

Onivyde (irinotecan liposome injection) is a liposomal formulation of the topoisomerase I inhibitor irinotecan approved for treatment of metastatic (advanced) pancreatic cancer already treated with gemcitabine-based chemotherapy. Onivyde is given in combination with fluorouracil and leucovorin. In clinical trials, patients who received Onivyde plus fluorouracil/leucovorin lived an average of 6.1 months, compared to 4.2 months for those treated with only fluorouracil/leucovorin. Risks of severe neutropenia and diarrhea are possible, as well as more common side effects like fatigue, vomiting, nausea, decreased appetite, inflammation in the mouth (stomatitis) and fever.

Imlygic: First Oncolytic Virus Therapy FDA-Approved for Melanoma

Imlygic has not improved overall survival or affected metastatic melanoma that has spread to other organs Read More…

Melanoma is the leading cause of skin cancer-related deaths. The FDA has approved Imlygic (talimogene laherparepvec) a novel medication for the treatment of melanoma lesions in the skin and lymph nodes. Imlygic is a genetically modified live oncolytic herpes virus therapy injected directly into melanoma lesions that cannot be completely removed by surgery. Imlygic replicates inside the cancer cell which then ruptures and dies. In studies, 16.3 percent of those who received Imlygic had a decrease in the size of lesions, lasting at least six months, compared to 2.1 percent of participants who received the comparator therapy.

Endo’s Belbuca Buccal Film Wins Approval for Chronic Pain

Phase 3 studies involved patients with moderate to severe chronic low back pain Read More...

The FDA has approved Belbuca, the first buprenorphine analgesic developed with a dissolving film that is absorbed through the inner lining of the cheek for chronic pain management. Belbuca is a mu-opioid receptor partial agonist with a long duration of action. Belbuca is to be used in both opioid-naïve and opioid-experienced patients who require around-the-clock treatment and for whom alternative pain treatment options are inadequate. Belbuca, a Schedule III controlled substance, is expected to be available in the U.S. during the first quarter of 2016 in seven dosage strengths ranging from 75 μg to 900 μg given every 12 hours.

Yondelis Okayed for Treatment of Specific Soft Tissue Sarcomas

In 2014, an estimated 12,000 cases of STS were diagnosed in the U.S. Read More...

Soft tissue sarcoma (STS) is a disease in which cancer cells form in soft tissues, including the muscles, tendons, fat, blood vessels, lymph vessels, nerves and tissues around joints. In response, FDA has approved Janssen’s cancer drug Yondelis (trabectedin) for the treatment of two specific STS conditions – liposarcoma (in fat cells) and leiomyosarcoma (in smooth muscle cells) – that cannot be removed by surgery or is advanced. Yondelis is approved for patients who previously received the cancer drug anthracycline. In trials, Yondelis delayed tumor growth on average 4.2 months, compared to 1.5 months with dacarbazine.

Strensiq First Approved Drug for Rare Hypophosphatasia

Strensiq’s approval came via FDA’s Breakthrough Therapy Designation and Priority Review programs Read More...

This past week, FDA approved Alexion’s Strensiq (asfotase alfa), an enzyme replacement and first approved therapy for patients with perinatal, infantile, and juvenile onset hypophosphatasia (HPP). HPP is a rare, genetic disease that can result in rickets and softening of the bones, skeletal abnormalities, muscle weakness, seizures, pain, respiratory failure and premature death. Strensiq injection is given 3 or 6 times per week. Strensiq works by replacing the enzyme known as “tissue-nonspecific alkaline phosphatase”, an enzyme responsible for formation of an essential mineral in normal bone.