The Phase III NALA trial is a randomized trial of PB272 plus Xeloda
versus Tykerb plus Xeloda
in patients with third-line HER2-positive metastatic breast cancer.
With this approval, the indication of Xeloda
has been changed into gastric cancer, covering the current indication of advanced or recurrent gastric cancer, which is not amenable to curative resection.
Tykerb was approved by the FDA in 2007, and by the European Medicines Agency (EMA) in 2008, for use in locally-advanced or metastatic breast cancer, in combination with Xeloda
Mylan, a United States-based pharmaceutical company, has introduced Capecitabine Tablets USP, 150mg and 500mg, the generic version of Genentech's Xeloda
Tablets, it was reported yesterday.
The decision is based on results from the Phase III study in which people previously treated with Herceptin and a taxane for their HER2-positive advanced breast cancer were randomized to receive either Kadcyla or a standard treatment, lapatinib and Xeloda
, una quimioterapia para canceres colorrectal y de mama, con ventas por 647 millones de dolares en 2011 para sus creadores, la estadunidense Genentech y la suiza Roche.
He was instrumental in developing and launching several indications of Xeloda
and MabThera shaping the drugs successes.
The assessment affects nineteen centrally authorised medicines as well as various medicines that have been nationally authorised: Avastin, Bondenza, Bondronat, Bonviva, Cellcept, Fuzeon, Herceptin, Invirase, Mabthera, Mircera, Neorecormon, Pegasys, Roactemra, Tamiflu, Tarceva, Viracept, Xeloda
, Xenical and Zelboraf.
1 months for those in the control arm who took Xeloda
and GlaxoSmithKline Plc's Tykerb.
The drug will compete with Roche Holding AG's Xeloda
and Bristol-Myers Squibb Co.
The National Institute for Health and Clinical Excellence (Nice) issued its final draft of guidance today, advising against NHS funding for the pill Tyverb - also known as lapatinib - in combination with the oral chemotherapy drug Xeloda