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SORAFENIB

200MG TABLET 02284227

NEXAVAR

BAY

  • 1.

    For use as a single agent second line treatment in patients with documented evidence of histologically confirmed advanced or metastatic clear cell renal cell carcinoma, considered to be intermediate or low risk (according to Memorial Sloan-Kettering (MSKCC) prognostic score, see below), have an ECOG performance status of 0 or 1 and progressed after prior cytokine therapy (or intolerance) within the previous 8 months. In any one patient all of the following conditions must be met:

    • Sorafenib may be a second line option only after cytokine therapy.

    • Sorafenib may not be used after another tyrosine kinase inhibitor (i.e., sunitinib) as

sequential therapy. In the event of severe toxicity within the first 8 weeks of therapy, a switch to another tyrosine kinase inhibitor (i.e., sunitinib) may be allowed.

2.

For use in patients with Child-Pugh Class A advanced hepatocellular carcinoma, who have progressed on trans-arterial chemoembolization (TACE) or are not suitable for the TACE procedure, and have an ECOG performance status of 0 to 2. Renewal of coverage requires no further progression of the patient’s disease as evidenced by radiological or scan results. Copies of the results must accompany the Special Authorization.

SUNITINIB 12.5MG CAPSULE

02280795

SUTENT

PFI

25MG CAPSULE 02280809

SUTENT

50MG CAPSULE 02280817

SUTENT

PFI

PFI

  • 1.

    For use as a single agent first line treatment in patients with documented evidence of histologically confirmed advanced or metastatic clear cell renal cell carcinoma who have an ECOG performance status of 0 or 1. In any one patient all of the following conditions must be met:

    • Sunitinib may be a first line option.

    • Sunitinib may not be used after another tyrosine kinase inhibitor (i.e., sorafenib) as

sequential therapy. In the event of severe toxicity within the first 8 weeks of therapy, a switch to another tyrosine kinase inhibitor (i.e., sorafenib) may be allowed.

2.

For use as a single agent for the treatment of advanced gastrointestinal stromal tumor (GIST) patients after failure of imatinib due to intolerance or resistance.

PEI Drug Programs Update - Issue 09-01- Page 2

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