Melanoma

FDA Approves Options for Melanoma, Soft Tissue Sarcomas

Imlygic – Melanoma

The FDA has approved Imlygic (talimogene laherparepvec) for the treatment of melanoma lesions in both the skin and lymph nodes.1

Imlygic, a genetically modified live oncolytic herpes virus therapy, is the first drug of its kind to be approved by the FDA. The drug is injected directly into melanoma lesions where it replicates within cancer cells, rupturing them.
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Imlygic is administered in a series of injections into lesions, with doses following the initial injection at 3 weeks, then every 2 weeks for 6 months.

The safety and efficacy of Imlygic was evaluated in a study of 436 participants with metastatic melanoma. Participants were randomized between the drug and a comparable competitor for 6 months, or until there was no longer injectable lesions present. Overall, 16.3% of participants who received Imlygic saw decreases in the size of their lesions, lasting a minimum of 6 months, compared to 2.1% of those using the competitor.

The most common side effects reported were fatigue, chills, fever, and nausea.

Yondelis – Soft Tissue Sarcomas

The FDA has approved Yondelis (trabectedin) for the treatment of specific soft tissue sarcomas (STS) including liposarcoma and leiomyosarcoma, that cannot be treated with surgery. The treatment is approved for patients who received previous chemotherapy containing anthracycline.2

The safety and effectiveness of the chemotherapy were evaluated in a study of 518 participants with metastatic or recurrent STS randomly assigned to either Yondelis or dacarbazine. Participants who received Yondelis saw delays in tumor growth that occurred 4.2 months after treatment initiation, compared to those receiving dacarbazine who saw disease progression at 1.5 months.

Yondelis carries a warning of severe and fatal blood infections, muscle tissue breakdown, liver damage, and tissue necrosis, as well as heart failure. 

Strensiq – Hypophosphatasia

The FDA has approved Strensiq (asfotase alfa) for the treatment of the rare metabolic disease, perinatal, infantile, and juvenile-onset hypophosphatasia (HPP).3

The drug is the first option for the treatment of HPP to see approval from the FDA.

Strensiq is administered via injection 3 or 6 times weekly, and works by replacing the enzyme responsible for the formation of minerals found in normal bone.

The drug’s safety and efficacy were evaluated in a trial of 99 patients with HPP. Overall, 97% of patients given Strensiq were alive at 1 year of age compared with 42% of control patients.

The most common side effects were hypersensitivity reactions, nausea, dizziness, lipodystrophy, and ectopic calcification of the eyes and kidney.

—Michael Potts

References:

  1. FDA. FDA approves first-of-its-kind product for the treatment of melanoma [press release]. October 27, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm469571.htm.
  2. FDA. FDA approves new therapy for certain types of advanced soft tissue sarcoma [press release]. October 23, 2015. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm468832.htm.
  3. FDA. FDA approves new treatment for rare metabolic disorder [press release]. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm468836.htm.