GlaxoSmithKline announced it has
received positive data from an interim analysis of its Phase III trial of Tykerb in advanced breast cancer, and as
such, ended enrollment for the trial after it found Tykerb in combination with Xeloda delayed the time to disease
progression by more than 50 percent, compared to Xeloda alone. None of the breast cancer patients in the trial had responded to Herceptin or other drugs.
“We are extremely encouraged by this data which suggest that Tykerb may offer significant benefit as an oral medication in combination with chemotherapy for patients with advanced or metastatic breast cancer, and whose disease has progressed on previous treatment regimens, including Herceptin,” said Paolo Paoletti, M.D., Senior Vice President of the Oncology Medicine Development Center at GlaxoSmithKline.
At this time, Tykerb is an experimental drug that does not have regulatory approval in any country for any use outside of clinical trials. GlaxoSmithKline plans to file marketing applications for Tykerb with the Food and Drug Administration and European regulators in the second half of the year.
1. According to NCI's March 31, 2006 official cancer information website on "state of the art" chemotherapy for recurrent or metastatic breast cancer, it is unclear whether single-agent chemotherapy or combination chemotherapy is preferable for first-line treatment. At this time, no data support the superiority of any particular regimen.
Single agents that have shown activity in metastatic breast cancer:
Anthracyclines.
Doxorubicin, Epirubicin, Liposomal doxorubicin, Mitoxantrone.
Taxanes.
Paclitaxel, Docetaxel, Albumin-bound nanoparticle paclitaxel (ABI-007 or Abraxane)
Alkylating agents.
Cyclophosphamide.
Fluoropyrimidines.
Capecitabine,5-FU.
Antimetabolites.
Methotrexate.
Vinca alkaloids.
Vinorelbine,Vinblastine,Vincristine.
Platinum.
Carboplatin,Cisplatin.
Other.
Gemcitabine, Mitomycin C.
Combination regimens that have shown activity in metastatic breast cancer:
CA: cyclophosphamide and doxorubicin.
Docetaxel and doxorubicin.
CAF: cyclophosphamide, doxorubicin, 5-fluorouracil.
CMF: cyclophosphamide, methotrexate, 5-fluorouracil.
Doxorubicin and paclitaxel.
Docetaxel and capecitabine.
Vinorelbine and epirubicin.
Oral-Dose Agents:
Letrozole
Exemestane
Anastrozole
Tamoxifen
Toremifene
Xeloda
Posted at 12:39PM on Apr 5th 2006 by Gregory D. Pawelski