FDA Approves New Treatment to Reduce the Risk of Breast Cancer Returning

Excerpt:

“The U.S. Food and Drug Administration today approved Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer. For patients with this type of cancer, Nerlynx is the first extended adjuvant therapy, a form of therapy that is taken after an initial treatment to further lower the risk of the cancer coming back. Nerlynx is indicated for adult patients who have been previously treated with a regimen that includes the drug trastuzumab.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


FDA Grants Orphan Drug Designation to Tucatinib for Brain Metastases

Excerpt:

“The FDA granted orphan drug designation to tucatinib for the treatment of patients with breast cancer whose disease metastasized to the brain, according to the drug’s manufacturer.

“Tucatinib (ONT-380, Cascadian Therapeutics) is an investigational, orally bioavailable, potent tyrosine kinase inhibitor that is highly selective for HER-2 without significant inhibition of EGFR, which has been associated with significant toxicities.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


Dual HER2 Blockade Superior to Single Blockade for HER2+/HR+ Breast Cancer

Excerpt:

“Dual blockade of HER2 with lapatinib plus trastuzumab and an aromatase inhibitor (AI) was superior to single blockade with trastuzumab plus an AI in postmenopausal women with HER2-positive, hormone receptor (HR)-positive metastatic breast cancer, according to the results of the phase III ALTERNATIVE study (abstract 1004) presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2–6 in Chicago.

” ‘Dual HER2 blockade with this triplet of lapatinib/trastuzumab and an AI can offer an effective and well-tolerated chemotherapy-sparing option for patients who are not intended or appropriate for chemotherapy,’ said researcher William J. Gradishar, MD, of the Robert H. Lurie Comprehensive Cancer Center at Northwestern University in Chicago, who presented the results.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


Oral SERD Promising in ER-Positive Breast Cancer With ESR1 Mutations

Excerpt:

“The investigational third-generation nonsteroidal oral selective estrogen receptor degrader (SERD) RAD1901 was associated with a 23% objective response rate among 40 heavily pretreated women with estrogen receptor (ER)-positive, HER2-negative breast cancer, according to authors of a phase I dose-escalation and safety cohort study (NCT02338349) presented (abstract 1014) at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2–6 in Chicago.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


Lilly Builds Upon Body of Data for Abemaciclib with Phase 3 MONARCH 2 Data Demonstrating Superior Progression-Free Survival in Advanced Breast Cancer

Excerpt:

“Eli Lilly and Company (NYSE: LLY) today announced that results from the Phase 3 MONARCH 2 study showed that abemaciclib, a cyclin-dependent kinase (CDK)4 & 6 inhibitor, in combination with fulvestrant, significantly improved progression-free survival (PFS) compared to treatment with fulvestrant alone in women with hormone-receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer who have relapsed or progressed after endocrine therapy (median PFS, 16.4 vs. 9.3 months, respectively, HR: 0.553; 95% CI: 0.449, 0.681, P < .0000001). The data were presented at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #1000) and simultaneously published online in the Journal of Clinical Oncology.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


Final TH3RESA, EMILIA Results Confirm Role of Trastuzumab Emtansine in HER2+ Breast Cancer

Excerpt:

“Final results from two large phase III trials confirm that the drug-antibody conjugate trastuzumab emtansine improves overall survival (OS) over other treatment options in patients with previously treated HER2-positive metastatic breast cancer. The results of the EMILIA and TH3RESA trials confirm the agent’s role in this setting.

“Trastuzumab emtansine, which links the antibody trastuzumab with the cytotoxic microtubule inhibitor DM1, was approved based on earlier results of the EMILIA study. The new analysis of that trial offers approximately twice the length of follow-up, at a median of 24.1 months.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


Final TH3RESA, EMILIA Results Confirm Role of Trastuzumab Emtansine in HER2+ Breast Cancer

Excerpt:

“Final results from two large phase III trials confirm that the drug-antibody conjugate trastuzumab emtansine improves overall survival (OS) over other treatment options in patients with previously treated HER2-positive metastatic breast cancer. The results of the EMILIA and TH3RESA trials confirm the agent’s role in this setting.

“Trastuzumab emtansine, which links the antibody trastuzumab with the cytotoxic microtubule inhibitor DM1, was approved based on earlier results of the EMILIA study. The new analysis of that trial offers approximately twice the length of follow-up, at a median of 24.1 months.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


FDA Panel Backs Novel Anti-HER2 Drug for Breast Cancer

Excerpt:

“Another potential drug for HER2-positive breast cancer received strong numeric support from an FDA advisory committee, tempered by reservations about a broad indication, modest clinical benefit, and toxicity issues.

“By a 12-4 vote, the Oncologic Drugs Advisory Committee (ODAC) supported FDA approval of the dual HER2/EGFR inhibitor neratinib for early HER2-positive breast cancer that relapses after trastuzumab (Herceptin) maintenance therapy.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.


Abemaciclib Improves PFS in Phase III MONARCH 3 Breast Cancer Trial

Excerpt:

“Adding abemaciclib to letrozole or anastrozole improved progression-free survival (PFS) compared with either aromatase inhibitor alone in women with HR+/HER2-negative breast cancer enrolled in the phase III MONARCH 3 study, according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor.

“MONARCH 3 (NCT02246621) is the second phase III trial of abemaciclib to demonstrate improved PFS in patients with HR+/HER2-negative breast cancer. In March, Lilly announced that in the MONARCH 2 study, combining abemaciclib with fulvestrant extended PFS compared with fulvestrant alone in patients who had progressed during or within 1 year of receiving endocrine therapy in the neoadjuvant or adjuvant setting, or during frontline endocrine treatment for metastatic disease.”

Go to full article.

If you’re wondering whether this story applies to your own cancer case or a loved one’s, we invite you to use our ASK Cancer Commons service.