Targeted cancer therapies: FDA approval overview.

Abstract

2537 Background: The development of targeted therapies requires the identification of molecular targets known to play a key role in cancer cell growth and survival. Methods: Review of clinical trials leading to new drug approvals for targeted cancer therapies. Results: The Table below summarizes the targeted cancer therapies approved by the FDA. Conclusions: Based on experience from the targeted cancer therapies currently approved, we conclude: (1) Molecular targets should optimally be identified prior to the initiation of registration trials. (2) In general, commercial tests to select patients with molecular markers should be validated concurrently with the drug development program. Exceptions may be in diseases where the molecular markers are expressed in the majority of patients such as CD20 antigens in follicular NHL and Bcr-Abl in CML. Molecular targets Approved drugs Indication Estrogen receptors SERMS: tamoxifen, toremifene, fulvestrant aromatase inhibitors: anastrozole,exemestane, letrozole Breast Bcr-Abl Imatinib mesylate, dasatinib, nilotinib CMLALL c-kit mutation Imatinib mesylate GIST EGFR Cetuximab, panitumumabgefitinib, erlotinib Colorectal, Lung CD-25 Deunileukin diftitox CTCL CD33Antigen Gemtuzumab ozogamicin CD33 + AML CD20 Rituximab, tositumomab +I131, ibritumomab, 90Y ofatumumab B-cell NHL CLL CD52 Alentuzumab B-cell CLL HER2 neu + Trastuzumab, lapatinib Breast Tyrosine kinases Sunitinib, pazopanib, sorafenib Renal cell, hepatocellular No significant financial relationships to disclose.