EU, US Approvals for Faslodex Combinations

Excerpt:

“AstraZeneca’s Faslodex has been cleared on both sides of the Atlantic for use in combination with a CDK4/6 inhibitor.

“In the EU, the drug’s use has been approved for use alongside the CDK4/6 inhibitor palbociclib to treat a certain form of breast cancer, in the US it can be prescribed in combination with the CDK4/6 inhibitor abemaciclib.

“Both the European Commission and US Food and Drug Administration have approved the combination for the treatment of hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) locally advanced or metastatic breast cancer in women who have received prior endocrine 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.


FDA Grants Priority Review to Frontline Abemaciclib for HR+/HER2- Advanced Breast Cancer

Excerpt:

“The FDA has granted a priority review to a new drug application (NDA) for abemaciclib (Verzenio) for use in combination with an aromatase inhibitor for the frontline treatment of women with hormone receptor (HR)-positive, HER2-negative advanced or metastatic breast cancer, according to Eli Lilly and Company, the manufacturer of the CDK4/6 inhibitor.

“The NDA was based on data from the phase III MONARCH 3 trial in which the addition of abemaciclib to anastrozole or letrozole reduced the risk of progression or death by 46% compared with the nonsteroidal aromatase inhibitor (NSAI) alone for previously untreated patients with HER2-negative, HR-positive advanced breast cancer.”

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 Approves Verzenio for Hormone Receptor-Positive, HER-2-Negative Breast Cancer

Excerpt:

“The FDA approved abemaciclib for the treatment of women with hormone receptor-positive HER-2-negative advanced or metastatic breast cancer who progressed following endocrine therapy.

The agency approved abemaciclib (Verzenio, Eli Lilly) — an investigational cyclin-dependent kinase 4/6 inhibitor —in combination with fulvestrant (Faslodex, AstraZeneca) following progression on endocrine therapy, and as a monotherapy for patients with metastatic disease previously treated with endocrine therapy and chemotherapy.”

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.


ESMO: Lilly Breast Cancer Drug Keeps Pace With Pfizer, Novartis Rivals

Excerpt:

“Eli Lilly and Co.’s experimental breast cancer drug abemaciclib significantly cut the risk of disease progression in a late-stage trial, bolstering the drug’s potential to become a new source of growth for the Indianapolis pharma’s oncology business.

“Updated results from a late-stage study known as MONARCH 3, presented over the weekend at the European Society of Medical Oncology’s annual meeting, showed abemaciclib in combination with an aromatase inhibitor extended progression-free survival in previously untreated patients with metastatic breast cancer.

“Eli Lilly has previously said abemaciclib could be best in class, yet it’s not clear whether the data disclosed to date will be enough to outshine rival drugs already marketed by Pfizer Inc. and Novartis AG.”

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.


Expert Discusses Abemaciclib Potential in HR+/HER2- Breast Cancer Patients With Brain Mets

Excerpt:

“Abemaciclib penetrated brain metastases and had antitumor activity in patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer, preliminary evidence suggests.

“Results were presented in a poster at the 2017 ASCO Annual Meeting for 23 patients from a stage 1 efficacy analysis from a phase II study.

” ‘What we found were 2 patients who experienced partial responses within the CNS, suggesting there is activity of the agent in the brain and in patients who have HR-positive disease,’ explained lead author Sara M. Tolaney, MD, MPH.”

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 Active in HR+/HER2- Breast Cancer Patients With Brain Mets

Excerpt:

“Preliminary evidence suggests that abemaciclib penetrated brain metastases and had antitumor activity in patients with hormone receptor (HR)-positive, HER2-negative metastatic breast cancer.

“Results were presented in a poster at the 2017 ASCO Annual Meeting for 23 patients from a stage 1 efficacy analysis from a phase II study.

” ‘What we found were 2 patients who experienced partial responses within the CNS, suggesting there is activity of the agent in the brain and in patients who have HR-positive disease,’ explained lead author Sara M. Tolaney, MD, MPH.”

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.


The Trouble With KRAS


Mutations in the gene that encodes the KRAS protein are frequently encountered in various human cancers. They are found in about 30% of non-small cell lung cancers (NSCLCs), making KRAS the single most common gene mutated in this cancer. The rate of KRAS mutations in other cancers, such as pancreatic or colorectal, is even higher.

A mutant KRAS protein that is always in the “on” position activates many signaling pathways, many of which lead to unrestrained growth and proliferation of cancer cells. This makes KRAS an appealing treatment target. However, challenges abound, and researchers are exploring several different approaches to treating KRAS-mutant cancers.

Unlike mutations in proteins known as receptor tyrosine kinases, like EGFR or ALK, mutated KRAS is a very difficult protein to target with cancer drugs. (So much so that the National Institutes of Health (NIH) has undertaken a special effort to intensify the effort towards successful targeting of mutant KRAS, known as the RAS Initiative.) Continue reading…


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.