FDA approves expanded use of breast cancer drug
PHILADELPHIA The Food and Drug Administration has given an additional approval to a breast cancer drug made by GlaxoSmithKline, GSK announced Friday.
The FDA approved Tykerb (lapatinib) combined with Novartis’ Femara (letrozole) as an all-oral, first-line treatment for postmenopausal women with hormone receptor-positive metastatic breast cancer that overexpresses the HER2 protein. HER2 is involved in normal cell growth, but can contribute to cancer when found on cancer cells, and between 25% and 30% of breast cancers overexpress the protein; 60% to 70% of breast cancer cases in the United States and Europe are hormone receptor-positive.
“This combination of Tykerb plus Femara is an example of advancing science and improving patient care,” GSK Oncology research and development SVP Paolo Paoletti said. “This regimen attacks two specific receptors that drive cancer growth. Women battling this disease now have the opportunity to delay the use of traditional cytotoxic chemotherapy, which is an exciting possibility for them.”
Tykerb already had approval as a combination with Roche’s Xeloda (capecitabine) chemotherapy in patients with HER2 advanced or metastatic breast cancer who had received prior therapy with anthracycline chemotherapy and Genentech’s Herceptin (trastuzumab). So far, however, Tykerb combined with Femara — or any other drug belonging to Femara’s class, known as aromatase inhibitors — has not been compared with a treatment regimen based on Herceptin and chemotherapy.
Lupin receives FDA approval for hypertension generic
BALTIMORE The Food and Drug Administration has given approval to a generic version of a drug used to treat high blood pressure made by an Indian drug maker.
Lupin Pharmaceuticals announced Thursday that it had received approval for perindopril erbumine tablets, used to treat essential hypertension and management of coronary artery disease.
The drug is a generic version of Solvay Pharmaceuticals’ Aceon, which had sales of $24 million during the 12-month period ending in September 2009, according to IMS Health.
Loose ends should be tied to make e-prescribing a reality
WHAT IT MEANS AND WHY IT’S IMPORTANT Relative to the national chains, independent pharmacies have limited resources and, given the importance and benefit of e-prescribing, further helping to facilitate the adoption of e-prescribing via grants — not to mention facilitating two-way communication between prescribers and pharmacists — is critical to help push overall adoption closer to the finish line.
THE NEWS: (NCPA: E-prescribing should be more efficient in two-way communication, cost. For the full story, click here)
As stated in the article, the National Community Pharmacists Association, at a recent e-prescribing committee, recommended providing grants to offset implementation and transaction fee costs and making two-way communication between prescribers and pharmacists easier.
In written testimony at a hearing of the Department of Health and Human Services’ Health Information Technology Policy Committee Information Exchange Workgroup, the NCPA acknowledged that community pharmacists have a vested interest in making e-prescribing work but yet cost challenges remain.
E-prescribing has been praised especially in recent years as it has been shown to increase the likelihood that patients will get their prescriptions filled and, in turn, avoid more expensive medical procedures. There’s also less of a chance for errors compared with paper prescriptions.
E-prescribing has achieved impressive milestones in recent years but the journey is far from over. In October 2009, e-prescribing network provider Surescripts announced that 23% of all office-based physicians, nurse practitioners and physician assistants in the United States are now e-prescribing. At that rate, Surescripts projected that its total number of active e-prescribers in 2009 would more than double the 74,000 active e-prescribers at the end of 2008.