February 24, 2016
By Alex Keown, BioSpace.com Breaking News Staff
SAN FRANCISCO – Genentech is under fire following a lawsuit filed by nine cancer care centers for shipping less than labeled amounts of its breast cancer drug Herceptin, the San Francisco Business Times reported this morning.
The lawsuits claim that freeze-dried packages of Herceptin failed to produce the correct concentration of the drug when it was added to the Genentech-provided liquid it mixes with. As a result, the cancer centers were required to purchase more Herceptin, the Times reported. The cancer centers said they should have been able to combine 20.952 milliliters of fluid solution, however, the cancer centers said the mixture only yielded 20.2 milliliters. The cancer centers said the yield total is important since the breast cancer drug is “dosed at milliliters per kilogram of a person’s weight,” the Times reported.
One of the cancer centers, Tennessee Oncology, said it was seeking monetary damages to cover the costs of the additional Herceptin it was forced to acquire in order to provide treatment for its patients, The Tennessean reported earlier this month. In its lawsuit, Tennessee Oncology said “the discovery of this shortage was made more difficult because of Genentech’s decision to market Herceptin in multi-dose vials in the United States,” the Tennessean reported.
Other Herceptin lawsuits against Genentech have been filed in New York, Florida, Oklahoma, Minnesota, Virginia and Washington, D.C.
With multiple lawsuits, a judicial panel is expected to decide next month whether to transfer the cases to the U.S. District Court for the Northern District of Oklahoma, the Times said.
Because of pending litigation, Genentech did not reply to the Times’ questions about the lawsuits.
This is not the first time there have been questions about Herceptin delivery. In March 2015, a survey, released by health care services company Novation, noted questions about the distribution of the drug after Genentech switched its distribution methods. About 81 percent of survey participants said Genentech’s move from a broader network of distributors to a handful of specialty distributors for its medications had a significant impact on expenses. Additionally 63 percent said deliveries have become unreliable and 88 percent reported the change caused a delay in patient treatment because the medication was unavailable. In the fall of 2014, California-based Genentech informed the hospital systems it serves that the three oncology drugs would only be available through six specialty distributors. The company said the change was necessary to improve distribution management, and to ensure supply when there are manufacturing challenges.
Herceptin, approved in 2002, has been hailed for its efficacy in treating HER-2-positive breast cancer, which is caused by the over production of the HER-2 gene in tumor cells. Last year Genentech reported Herceptin mixed with a complimentary drug pertuzumab, marketed under the brand name Perjeta, and docetaxel, a standard medication in chemotherapy, can extend the lives of some patients battling the often fatal advanced HER-2 positive breast cancer. The growth of tumors in patients who received the trio of drugs slowed and the patients, on average, lived about 16 months longer than average patients with HER-2, Genentech said. Patients diagnosed with advanced HER-2 often have a life expectancy of two to three years.
