Personalized Medicine

Talzenna (Talazoparib) New PARP Inhibitor Approved for the Treatment of HER2-Negative Advanced Breast Cancer with Germline BRCA Mutation

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - Breast Cancer, FDA Approvals, News & Updates

Two human genes, BRCA1 and BRCA2 (BRCA1/2), produce proteins that block the growth of cancer, such as breast or ovarian cancer. These proteins ensure the stability of each cell’s genetic material and help to repair damaged DNA. A mutation in either BRCA results in these proteins not functioning correctly. Specifically, DNA damage may not be repaired effectively, which can lead to cancer. [ Read More ]

Lumoxiti (Moxetumomab Pasudotox-tdfk) First CD22-Directed Cytotoxin FDA Approved for Relapsed or Refractory Hairy-Cell Leukemia

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Leukemia

Hairy-cell leukemia (HCL) is a rare and indolent hematologic cancer. HCL, which is 4 to 5 times more frequent in men than in women, accounts for 2% of all leukemias. Approximately 1000 new cases of HCL are diagnosed in the United States annually. [ Read More ]

Lorbrena (Lorlatinib) Approved for the Treatment of Metastatic Non–Small-Cell Lung Cancer with ALK Mutation

Loretta Fala

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Lung Cancer

Lung and bronchus cancer, the second most common form of cancer, accounts for 13.5% of all new cancer cases in the United States. In 2018 alone, lung cancer was newly diagnosed in 234,030 individuals and accounted for 154,050 deaths. In fact, lung cancer is the leading cause of cancer-related mortality in men and women, and is responsible for more than 25% of all cancer deaths. The 5-year survival rate for patients whose lung cancer has spread regionally (to regional lymph nodes) is 29.7%, but that survival rate is only 4.7% for patients with distant metastases. [ Read More ]

Erleada (Apalutamide) First Drug Approved by the FDA for Nonmetastatic Castration-Resistant Prostate Cancer

Loretta Fala

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Prostate Cancer

Prostate cancer, the second most common type of cancer in men, is expected to affect 11.6% of all men during their lifetime. In fact, more than 3 million men in the United States are living with prostate cancer. It is estimated that in 2017, 161,360 men were newly diagnosed with prostate cancer, and 26,730 men died from the disease. [ Read More ]

Daurismo (Glasdegib) Approved, in Combination with Low-Dose Cytarabine, for Newly Diagnosed Acute Myeloid Leukemia in Older Adults or Those Unfit for Intensive Chemotherapy

Loretta Fala

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Leukemia

Acute myeloid leukemia (AML) is a cancer of the blood and bone marrow that is characterized by the production of abnormal myeloblasts, red blood cells, or platelets. AML originates in the bone marrow, but it often spreads into the blood and to other parts of the body, including the lymph nodes, liver, spleen, and central nervous system. [ Read More ]

Braftovi (Encorafenib) plus Mektovi (Binimetinib) Third BRAF/MEK Inhibition Combination Approved for Metastatic Melanoma with BRAF Mutation

Lisa A. Raedler, PhD, RPh

2019 Fourth Annual Oncology Guide to New FDA Approvals - FDA Approvals, News & Updates, Melanoma

Melanoma is the most dangerous form of skin cancer. The 5-year relative survival rate for Americans with distant melanoma is only 23%. The National Cancer Institute estimated that there were 91,270 new cases of skin melanoma and more than 9300 deaths from this disease in 2018. This deadly disease is also costly; in the United States, expenditures for the treatment of melanoma exceeded $3 billion in 2018. [ Read More ]

T-DM1 Reduces Residual Invasive Disease in Patients with HER2-Positive Breast Cancer After Chemotherapy

Phoebe Starr

June 2019, Vol 10, No 3 - Breast Cancer

The adjuvant use of the antibody-drug conjugate trastuzu­mab emtansine (T-DM1; Kadcyla) led to a clinically meaningful and significant improvement in disease-free survival versus trastuzumab (Herceptin) in patients with HER2-positive early breast cancer and residual invasive disease, despite the use of neoadjuvant chemotherapy plus HER2-targeted therapy. [ Read More ]

Personalized Neoadjuvant Immunotherapy Combinations Improve Outcomes in Stage III Melanoma

Wayne Kuznar

June 2019, Vol 10, No 3 - Melanoma

San Francisco, CA—Moving combination immunotherapy into the neoadjuvant setting for patients with stage III melanoma induces a higher rate of pathologic response than adjuvant therapy, said Christian U. Blank, MD, PhD, Division of Molecular Oncology & Immunology, Netherlands Cancer Institute, ­Amsterdam, at the 2019 ASCO-­SITC Clinical Immuno-Oncology Symposium. [ Read More ]

Adding PARP Inhibitor to Immune Checkpoint Blockade Improves Responses in Ovarian Cancer with BRCA Mutations

Wayne Kuznar

June 2019, Vol 10, No 3 - Ovarian Cancer

San Francisco, CA—Ovarian cancers with BRCA mutations are less immunogenic than other DNA repair–deficient tumors. Targeting the DNA damage response using PARP inhibitors may help to improve the modest responses of ovarian cancer seen with single-agent immune checkpoint inhibitors, said ­Panagiotis A. Konstantinopoulos, MD, PhD, Director of Translational Research, Division of Gynecologic Oncology, Dana-Farber Cancer Institute, Boston, at the 2019 ASCO-SITC Clinical Immuno-Oncology Symposium. [ Read More ]