GlaxoSmithKline's Tykerb (lapatinib) clears FDA March 13 for use in combination with Roche's Xeloda (capecitabine) for treatment of advanced or metastatic HER2-positive breast cancer. The kinase inhibitor is indicated for use in women who have received prior therapy, including Genentech's Herceptin (trastuzumab). Approval is based on a Phase III trial of 400 advanced or metastatic breast cancer patients with HER2 over expression or whose disease had progressed following treatment with Herceptin or other therapies. The group receiving Tykerb had a statistically significant improvement in time to progression, and tumor response rate was also higher in patients treated with Tykerb plus capecitabine. GSK is pricing Tykerb slightly below Herceptin, and is offering the product free of charge to patients who have no insurance coverage and have an income at or below 500 percent of the federal poverty level...
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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ZIN, the Dutch health technology assessment body, estimates that the number of patients eligible for treatment with a PARP inhibitor will be halved following a reassessment of drugs in the class.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
Extended-release stimulants will add a new ‘Limitation of Use’ about weight loss in children under 6 years, reflecting concerns about overuse from the Make America Healthy Again commission, a concern multiple studies did not find valid.