Recent moves by Roche and Genentech could expand the reach of Herceptin in Europe and the United States.
In February, Genentech submitted a supplemental Biologics License Application to the US Food and Drug Administration to enable the drug to be used as an adjuvant to treat early-stage Her2-positive breast cancer, while Roche Pharmaceuticals in Switzerland submitted a Marketing Authorization application to the European Medicines Agency for the same indication.
The drug is currently indicated only for metastatic — or stage IV — breast cancer, either in combination with paclitaxel or as a stand-alone treatment for women who have had chemotherapy.
Should the companies be granted the new indication, not only would manufacturers of Her2 diagnostics stand to gain, but also the drug that helped pave the way for pharmacogenomics may gain even more visibility and overcome reimbursement difficulties it has experienced in the UK.
“Obviously, there are more opportunities in early rather than later-stage breast cancer, and that is clearly what Roche and Genentech are targeting,” says Sreten Bogdanovich, managing partner of UK consultancy BioPhoenix.
Genentech has asked the FDA for a priority review designation for its BLA, which would require the agency’s response within six months.
After the FDA approved Herceptin in September 1998, the addition of a Her2 IHC diagnostic to the drug’s indication arguably led to a more favorable view of pharmacogenomic treatments by showing it was possible and cost effective to identify patients most likely to respond.
There are already signs that an early-stage indication would be welcomed by the market, which has already been using the drug for this indication off-label. “Clinical data showing significant efficacy in adjuvant breast cancer has led to growing adoption in this unapproved area,” said Roche in its 2005 year-end financial report.
— Chris Womack
US Patent 6,994,998. Base-modified nucleotides and their use for polymorphism detection. Inventors: Vincent Stanton, Jia Liu Wolfe, Tomohiko Kawate, Charles Allerson, and Gregory Verdine. Assignee: Sequenom. Issued: February 7, 2006.
This invention relates to methods used for detecting polymorphisms by substituting a base-modified nucleotide for a natural nucleotide in a polynucleotide. The base-modified nucleotide renders the polynucleotide more susceptible to cleavage at the sites of its incorporation than at sites consisting of natural nucleotides. The fragments obtained are then analyzed to determine the presence or absence of a polymorphism.
US Patent 7,005,139. Compositions and methods for the targeted delivery of agents to treat liver cancer. Inventors: Jeffrey Tze Fei Wong and Shui Ying Tsang. Assignee: Hong Kong University of Science and Technology. Issued: February 28, 2006.
The aim of this invention is to provide a liver-targeting delivery system of liposomal encapsulated therapeutic agents for use in cancer therapy. The abstract describes methods for the delivery of a drug to tissue expressing asialoglycoprotein receptors, and for inhibiting the proliferation of liver cancer by administering a composition containing doxorubicin encapsulated in desialyated glycoprotein-alpha1 coupled to a liposome.
Number of genes, from AATF to ZNF304, currently listed in PharmGKB that include primary data.
Precision Therapeutics closed a $20 million series B funding round. The funding will be used to commercialize the company’s ChemoFx assay, a cell-based test that quantifies a patient’s likely tumor response to single or multiple chemotherapeutic agents.
Monogram Biosciences and Dana-Farber Cancer Institute announced plans to conduct experiments using Monogram’s eTag assays to study signaling pathway activation and clinical responsiveness to targeted drugs in a range of cancers. Under the deal, Monogram will have rights to diagnostic and predictive medicine applications for all resulting products.
The Global Alliance for TB Drug Development and BG Medicine will collaborate to identify biomarkers for tuberculosis drug development. The effort will last six months, during which BG Medicine will use its proteomic and metabolomic platforms to analyze samples provided by Colorado State University. TB Alliance will fund the project, with help from a grant from the Netherlands Ministry of Foreign Affairs.
The FDA’s Center for Devices and Radiological Health released a draft guidance, entitled Pharmacogenetic Tests and Genetic Tests for Heritable Markers, which provides device manufacturers with clearer guidelines for generating data in support of new diagnostics.