JH: development of draft manuscript, review of advanced manuscript and approval of final version for submission.
TF and CS: development of study concept, interpretation of study data, development of draft manuscript, review of advanced manuscript and approval of final version for submission.
CG: development of study concept, statistical analyses, interpretation of study data, development of draft manuscript, review of advanced manuscript and approval of final version for submission.
The prognosis for GIST changed dramatically after the introduction of effective targeted treatments beginning with clinical trials for imatinib in 2000, and its subsequent approval for advanced GIST in 2002; sunitinib was approved for imatinib refractory/intolerant GIST in 2006; approval for adjuvant imatinib in 2008 (EU, 2009).
As conventional chemotherapy with platinum-based doublets is associated with improved clinical outcomes, but also potentially higher toxicity 1, the evaluation of molecularly targeted therapies has led to extensive investigation and several U.S. Food and Drug Administration FDAapprovalsals for advanced NSCLC 2– 5.
Some argue that the grand slam of cancer therapeutics, improved survival, be required for drug approval in advanced, incurable breast cancer.
The pleas and presentations came on the first day of a two-day hearing at which Genentech, the manufacturer of Avastin, is getting a chance to try to persuade the F.D.A. to reverse its decision made in December to revoke the drug's approval for advanced breast cancer.
41 Understanding of the biology of advanced RCC and the approval of several drugs for treatment has now meant that there are logical ways of combining the many therapeutic options for this disease.
Recently, the third-generation nonsteroidal AIs anastrozole and letrozole and the steroidal AI exemestane have been shown to be more effective than tamoxifen as first-line treatment in postmenopausal women with hormone-sensitive advanced disease, leading to approval in this treatment setting.
The identification of molecular targets relevant to thyroid cancer has led to significant gains in the treatment of patients with advanced thyroid cancer, including approval by the US Food and Drug Administration FDAA) of four targeted multikinase inhibitors (MKIs) – cabozantinib and vandetanib for medullary thyroid cancer (MTC) and sorafenib and lenvatinib for differentiated thyroid cancer (DTC).
