Preliminary results from a new study, unpublished but reported in a press release from the National Cancer Institute and widely disseminated in the public press, suggest that raloxifene (Evista) might be a better choice than tamoxifen (Nolvadex, and others) for prevention of breast cancer in high-risk postmenopausal women.

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali – Novartis), which was approved by the FDA in 2017 for use with an aromatase inhibitor or fulvestrant for treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer, has now been approved for use with an aromatase inhibitor for adjuvant treatment of HR-positive, HER2-negative stage II or III early breast cancer at high risk of recurrence. Kisqali can be used in patients with node-positive or node-negative disease. The CDK 4/6...

Adjuvant hormone therapy with anti-estrogen drugs has been shown to reduce disease recurrence and mortality in postmenopausal women with estrogen receptor (ER)-positive breast cancer. In recent years, aromatase inhibitors (AI) have become the preferred first-line hormonal treatment over tamoxifen for such patients.1,2

Pertuzumab (Perjeta – Roche/Genentech), a humanized monoclonal antibody, has been approved by the FDA for use in combination with trastuzumab (Herceptin) and docetaxel (Taxotere, and others) for first-line treatment of human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer.

The prognosis in breast cancer is generally poor for women with unresectable, locally advanced disease (inflammatory cancer or more than 10 positive lymph nodes) and for those with metastases. Autologous bone marrow transplantation - removing bone marrow from multiple sites under general anesthesia, giving high-dose chemotherapy with or without total body radiation, and reinfusing the bone marrow intravenously - is being tried in some of these patients.

Epirubicin, an analog of doxorubicin that has been available in Europe and Canada for 15 years, has now been approved by the FDA for adjuvant use after resection of the primary tumor in breast cancer patients with axillary node involvement.

A new albumin-bound formulation of paclitaxel (Abraxane - American Pharmaceutical Partners) has been approved by the FDA for treatment of metastatic breast cancer after failure of combination chemotherapy or relapse within 6 months of adjuvant chemotherapy. This formulation is free of polyoxyethylated castor oil (Cremophor), a solvent thought to contribute to the hypersensitivity reactions that occur frequently with standard paclitaxel (Taxol, and others) and are severe in about 3% of patients.

The FDA has approved the neoadjuvant (preoperative) use of pertuzumab (Perjeta – Genentech) in combination with trastuzumab (Herceptin) and docetaxel (Taxotere, and generics) for treatment of locally advanced, inflammatory, or early-stage HER2 (human epidermal growth factor receptor 2)-positive breast cancer patients with tumors >2 cm in diameter or node-positive disease. Pertuzumab in combination with trastuzumab and docetaxel was approved earlier for treatment of HER2-positive metastatic breast cancer. Pertuzumab is the first drug to be approved for neoadjuvant treatment of...

The FDA has approved datopotamab deruxtecan (Datroway – Daiichi Sankyo/AstraZeneca), a trophoblast cell-surface antigen-2 (Trop-2)-directed antibody and topoisomerase inhibitor conjugate, for treatment of adults with unresectable or metastatic hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer who received prior endocrine-based therapy and chemotherapy for unresectable or metastatic disease.

The oral cyclin-dependent kinase (CDK) 4/6 inhibitor ribociclib (Kisqali – Novartis) has been approved by the FDA for use in combination with an aromatase inhibitor for first-line endocrine-based therapy in postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. Ribociclib is also available copackaged with the aromatase inhibitor letrozole (Femara, and generics) as Kisqali Femara Co-Pack. Ribociclib is the second CDK 4/6 inhibitor to be approved in the US for this indication;...