Breast cancer is the number one common malignancy in women. Worldwide, breast cancer accounts for 10% of all cancer incidence, 32% of female cancer incidence and 15% of female cancer mortality. According to the latest statistics published by the American Journal of Cancer in Clinicians, about 230,000 women in the United States suffered from breast cancer in 2011, accounting for 30% of new malignant tumors in women and ranking first in the incidence of malignant tumors in women. Compared with developed countries, China is a low incidence area for breast cancer, but the incidence of breast cancer has been increasing significantly in recent years, and there are currently about 470,000 breast cancer patients.
The market for breast cancer drugs has seen a significant increase in R&D investment by pharmaceutical companies in recent years. According to genengnews, a leading U.S. biotechnology website, the new breast cancer drugs currently in development offer new hope for the future treatment of the disease. The following are the major new breast cancer drugs under development worldwide.
Drug name: Fenitrol (everolimus, everolimus)
Developer: Novartis
Drug Class: Mammalian target of rapamycin (mTOR) protein inhibitor
Indications/stage of trial: Hepatocellular carcinoma; first- and second-line therapeutic agents for human epidermal growth factor receptor 2-positive (HER2+) breast cancer; lymphoma; non-functional tumor-like tumors. Studies for all of the above new indications are in Phase III clinical stages.
In July of this year, the US and EU approved a new indication for everolimus – in combination with exemestane for the treatment of advanced hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer in postmenopausal women after treatment with other methods.
Drug name: Avastin (Bevacizumab, bevacizumab)
Developer: Roche/Genentech
Drug class: monoclonal antibody, vascular endothelial growth factor (VEGF) inhibitor
Indications/stage of trial: In the U.S., bevacizumab is in registration application for the indication of platinum-sensitive recurrent ovarian cancer; studies as a first-line agent for the treatment of metastatic breast and metastatic ovarian cancer are also in Phase III clinical stage. In the European Union, bevacizumab is in Phase III for the treatment of platinum-resistant recurrent ovarian cancer; in registration review for the treatment of progressive metastatic colorectal cancer; and as adjuvant therapy for HER2- and HER2+ breast cancer, adjuvant therapy for non-small cell lung cancer (NSCLC), first-line treatment for glioblastoma (GBM) pleomorphism, and high-risk carcinoid tumors (a tumor that super-produces small molecule peptides or peptide hormones). or peptide hormone tumors) are also in Phase III clinical studies.
Drug Name: Buparlisib (BKM120)
Developer: Novartis
Class: Pan-PI3K inhibitor
Indications/Stage of Trial: Buparlisib for metastatic breast cancer studies are in Phase III clinical and validation Phase I/II clinical phases; studies in combination with fulvestrant for postmenopausal women with hormone receptor-positive, HER2- locally advanced or in combination with an aromatase inhibitor (AI) for metastatic breast cancer are in Phase III clinical phases; studies in combination with fulvestrant for postmenopausal women with hormone receptor-positive The combination of fulvestrant for the treatment of hormone receptor-positive, HER2-, locally advanced or metastatic breast cancer in postmenopausal women previously treated with aromatase inhibitors or mTOR inhibitor-based therapy is in Phase III clinical stage; the combination of paclitaxel for the treatment of HER2-, inoperable locally advanced or metastatic breast cancer is in Phase III clinical stage; the combination of fulvestrant for the treatment of estrogen receptor-positive metastatic breast cancer in postmenopausal women is in Phase I clinical stage. clinical stage.
Drug name: Faslodex (Fulvestrant)
Developer: AstraZeneca
Class of drug: Estrogen receptor antagonist
Indications/Stage of Trial: Fulvestrant is in Phase III clinical trials as a first-line treatment for hormone receptor-positive metastatic breast cancer.
The FDA approved fulvestrant in 2002 for the treatment of hormone receptor-positive metastatic breast cancer in postmenopausal women who have been treated with anti-estrogen drugs (e.g., tamoxifen) but whose disease continues to deteriorate.
Drug name: Herceptin (Trastuzumab, Trastuzumab)
Developer: Roche and Halozyme
Drug class: Humanized monoclonal antibody with targeting and blocking HER2+ function
Indications/stage of trial: In Europe, a subcutaneous formulation of trastuzumab is enrolled in a study for the treatment of early-stage HER2+ breast cancer.
Approved indications for trastuzumab include use in early-stage HER2+ breast cancer that has spread to lymph nodes; HER2+ breast cancer that has not spread to lymph nodes and is estrogen receptor/progesterone receptor negative (ER-/PR-) or is at high risk. High risk is defined as estrogen receptor/progesterone receptor positive (ER+/PR+) with one of the following characteristics: tumor > 2 cm, age < 35 years or tumor grade 2 or 3. Trastuzumab may be used in combination with adriamycin, cyclophosphamide, paclitaxel or docetaxel, or in combination with both docetaxel and carboplatin, or alone after multiple treatments such as other chemotherapy based on anthracycline (adriamycin) drugs. Trastuzumab is also approved for use alone in the treatment of patients with HER2+ breast cancer who have received one or more courses of chemotherapy, and in combination with paclitaxel as first-line treatment for HER2+ breast cancer.
Drug name: Doxorubicin (Sorafenib, sorafenib)
Developer: Onyx Pharmaceuticals, Inc.
Drug class: Dual efficacy inhibitor and tyrosine kinase inhibitor targeting the RAF/MEK/ERK signaling pathway in tumor cells
Indications/stage of trial: Studies of sorafenib as an adjuvant in liver cancer, an adjuvant in kidney tumors, and a monotherapy drug for thyroid cancer are in Phase III clinical stage, and its combination with capecitabine for breast cancer is also in Phase III clinical stage.
Drug name: Perjeta (Pertuzumab, patuximab)
Developer: Roche/Genentech
Drug class: HER2/neu protein receptor antagonist
Indications/stage of trial: In the EU, pertuzumab is being studied in combination with trastuzumab and doxorubicin for the treatment of untreated HER2+ metastatic breast cancer or locally recurrent, inoperable, untreated or recurrent breast cancer after early treatment, and is currently under registration review.
The U.S. approved pertuzumab in combination with trastuzumab and doxorubicin for the treatment of HER2+ metastatic breast cancer that has not received anti-HER2 therapy or chemotherapy in June 2012. Switzerland approved the combination of pertuzumab with trastuzumab for HER2+ breast cancer and with doxorubicin for untreated advanced or locally recurrent breast cancer in August 2012.
Drug name: Ridaforolimus (MK-8669, AP23573, Deforolimus)
Developer: Acquired by Merck Sharp & Dohme through an exclusive worldwide license agreement with Ariad Pharmaceuticals
Class of drug: Oral mammalian target of rapamycin (mTOR) inhibitor
Indications/stage of trial: A controlled study of Ridaforolimus in combination with exemestane and dalotuzumab in combination with exemestane for breast cancer is in phase II clinical stage; a study of dalotuzumab in combination with dalotuzumab for breast cancer is in phase I clinical stage; a study of paclitaxel and carboplatin in combination with dalotuzumab for endometrial and ovarian cancer is in phase I clinical stage.
Drug name: Trastuzumab-DM1 (T-DM1, trastuzumab emtansine, RG3502)
Developer: Roche and linker technology developer ImmunoGen
Drug Class: Antibody-drug conjugates, including the antibody trastuzumab and the chemotherapeutic drug DM1 linked by a stable linker
Indications/stage of trial: Trastuzumab-DM1 is enrolled in the United States for the treatment of locally advanced or metastatic HER2+ breast cancer previously treated with trastuzumab and paclitaxel-based chemotherapy (not surgically resectable). It was granted priority review status on November 7 of this year and will undergo final review by the FDA in February 2013. In the European Union, the European Medicines Agency is reviewing a marketing authorization application for Trastuzumab-DM1 for the treatment of HER2+ metastatic breast cancer.
Other Breast Cancer Therapeutics in Development
Drug name: Tyverb/Tykerb (lapatinib, lapatinib)
Developer: GlaxoSmithKline
Drug class: HER2 and EGFR dual kinase inhibitor
Indications/Stage of Trial: Lapatinib in combination with trastuzumab for metastatic breast cancer study in registration; in Phase III clinical stage as adjuvant treatment for breast cancer study
Drug Name: Xgeva (denosumab, denosumab)
Developer: Amgen Corporation
Drug class: Fully human monoclonal antibody, RANK ligand (RANKL) inhibitor
Indications/Stage of Trial: The denosumab study to delay or prevent bone metastases from breast cancer is in Phase III clinical stage.
Drug Name: Yondelis (trabectedin, trabectedin)
Developer: Johnson & Johnson and PharmaMar, Inc.
Class of drug: Acts on gaps in short branches of DNA in tumor cells, interferes with cell division and gene transcription processes and DNA repair
Indications/Stage of Trial: In the United States, trabectedin is in Phase II clinical studies for the treatment of breast cancer.
Drug Name: Xtandi (Enzalutamide, MDV3100)
Developer: Medivation and Astellas
Drug class: Androgen receptor inhibitor
Indications/Stage of Trial: Enzalutamide for breast cancer study is in Phase I clinical stage.