San Antonio, TX—It is becoming increasingly clear that 2 agents are better than 1 in treating HER2-positive advanced breast cancer.

The latest evidence comes from the results of the phase 3 clinical trial CLEOPATRA (Clinical Evaluation of Pertuzumab and Trastuzumab), which were presented at the 2011 CTRC-AACR/San Antonio Breast Cancer Symposium by Jose Baselga, MD, PhD, Professor of Medicine, Harvard Medical School and Associate Director of the Massachusetts General Hospital Cancer Center, Boston.

San Diego, CA—Patients with multiple myeloma receiving bortezomib (Velcade) in the pivotal VISTA trial lived more than 1 year longer than those in the control group, according to the final, 5-year analysis of the study presented at the 2011American Society of Hematology annual meeting.

The FDA has revoked its previous accelerated (and conditional) approval for bevacizumab (Avastin, Genentech) for the treatment of metastatic breast cancer (MBC), citing safety concerns that outweigh its benefits in this patient population.

The FDA approved asparaginase Erwinia chrysanthemi (Erwinaze, Eusa Pharma) for the treatment of acute lymphoblastic leukemia (ALL) in patients with hypersensitivity to Escherichia coli–associated asparaginase and pegaspargase chemotherapy drugs used for the treatment of ALL.

Applying its priority review procedure, the FDA approved ruxolitinib (Jakafi, Incyte), an oral inhibitor of the Janus kinase (JAK) 1 and 2 gene, for the treatment of intermediate- and highrisk myelofibrosis (MF), including primary MF, postpolycythemia vera MF, and postessential thrombocythemia MF. Ruxolitinib is the first drug approved specifically for this indication. Ruxolitinib received accelerated approval (ahead of its regulatory date).

Cetuximab (Erbitux, Bristol-Myers Squibb) received a new indication for the treatment of recurrent or metastatic squamous-cell carcinoma of the head and neck, in combination with chemotherapy. The approval was based on an international phase 3 clinical trial of 442 patientswithmetastatic or recurrent squamous-cell cancer of the head and neck who had not received chemotherapy.

The FDAapproved an update to the label of bortezomib (Velcade, Takeda) to include the newly reported 5-year OS data showing survival advantage when the drug is added to melphalan and prednisone (VMP) for patients with previously untreated multiple myeloma.

These longest available follow-up data for patients with myeloma show that patients who received the VMP regimen continued to have signif - icantly longer OS (median 56.4 months) than those who received the melphalan and prednisone regimen without bortezomib (median, 43.1 months).

San Antonio, TX—Updated results from the phase 3 Breast Cancer Trials of Oral Everolinmus (BOLERO-2) showed that adding everolimus to the treatment regimen with the aromatase inhibitor exemestane more than doubles the time to disease progression in patients with advanced estrogen receptor (ER)-positive breast cancer whose disease has become refractory to hormonal therapy.

San Antonio, TX—The treatment of ductal carcinoma in situ (DCIS)— breast cancer confined to the ducts—is a clinical challenge, as patients carry varying risks of recurrence and may easily be undertreated or overtreated. But Genomic Health, which markets Oncotype DX for assessing risk of recurrence in invasive cancers, has developed a similar test for DCIS that may prove useful for individualizing treatment in this subset of breast cancer. The test is expected to become available for physicians for use on December 28, 2011.

San Antonio, TX—Two antiestrogen agents may be better than one in the treatment of metastatic hormone receptor-positive breast cancer patients, according to a study conducted by the Southwest Oncology Group (SWOG) clinical trials network and presented at the 2011 CTRC-AACR San Antonio Breast Cancer Symposium.

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