FDA approves Lilly pill for common advanced breast cancer

Eli Lilly's Verzenio was approved Thursday by the Food and Drug Administration for women and men with what's called HR-positive, HER2-negative breast cancer that has worsened after hormone therapy.
According to the FDA, about 72 percent of patients with breast cancer have this type.
The daily pill blocks certain enzymes that promote growth of cancer cells. It's to be used either alone, after hormone therapy and chemotherapy have stopped working, or in combination with a hormone therapy called fulvestrant.
Play
Current Time0:00
/
Duration Time0:00
Loaded: 0%
Progress: 0%
0:00
Fullscreen
00:00
Mute
Indianapolis-based Eli Lilly and Co. says Verzenio, which is taken until cancer resumes growing, will cost $10,948 per month. It's offering patients financial assistance, including 12 months with a minimal copayment for those with commercial insurance.
It will compete with two drugs in the same class, Pfizer Inc.'s blockbuster Ibrance and Novartis AG's recently approved Kisqali. Both cost about the same amount but can't be given as stand-alone treatments to those patients.
"Verzenio provides a new targeted treatment option for certain patients with breast cancer who are not responding to treatment," Dr. Richard Pazdur, director of the FDA's Oncology Center of Excellence, said in a statement.
In patient testing, cancer stopped worsening for patients taking Verzenio plus fulvestrant for just over 16 months on average, versus nine months for patients taking a dummy pill with fulvestrant. When given alone, testing showed about 20 percent of patients taking Verzenio had their tumors shrink at least partially for 8 ½ months on average.
Verzenio can cause serious side effects, including diarrhea, low white blood cell count and dangerous blood clots. More-common side effects include anemia, infections, fatigue and vomiting. Pregnant women should not take it.
The National Cancer Institute estimates that this year nearly 253,000 women will be diagnosed with breast cancer, and 40,610 will die of the disease.
Source:http://www.whio.com/news/fda-approves-lilly-pill-for-common-advanced-breast-cancer/bk4aygIAndZPcjfAFBNqhP/

Comments

Post a Comment

Popular posts from this blog

EMA validates Incyte’s MAA for retifanlimab to treat metastatic squamous cell anal carcinoma

Incyte, global biopharmaceutical company, announced the validation of the Company’s Marketing Authorization Application (MAA) for retifanlimab, an intravenous PD-1 inhibitor, as a potential treatment for adult patients with locally advanced or metastatic squamous cell anal carcinoma (SCAC) who have progressed on, or who are intolerant of, platinum-based chemotherapy. The European Medicines Agency’s (EMA) validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process. “While the incidence of SCAC is increasing in Europe, treatment options for advanced disease are limited in their effectiveness, and there are no approved options once patients have progressed on standard therapy,” said Lance Leopold, M.D., Group vice president, Immuno-Oncology Clinical Development, Incyte. “The EMA validation of the MAA for retifanlimab – which follows the recent US Food & Drug Administration acceptance of our Biologics License Application for Priority R...
Read more

Tumour-targeting drug paves way for bone cancer treatment

 The treatment of osteosarcoma, the most common tumour of bone, is challenging, but a new study is offering hope to the patients with this disease. The study led by The University of  Texas MD Anderson Cancer Centre  found that a drug, known as bone metastasis-targeting peptidomimetic (BMTP-11), has potential as a new therapeutic strategy for this devastating illness. Results from the preclinical study looked at BMTP-11 alone and in combination with the chemotherapy agent gemcitabine. Although osteosarcoma is a relatively rare cancer, it is a leading disease-related cause of death in children and young adults ages 10 to 20. However, over the last 25 years, the five-year survival rate has remained unchanged, and the treatment options for these patients are few. In addition, the side effects of available treatment options often are significant and cumulative, and may cause other health problems and damage to major organs. "What's novel about this treatment is that...
Read more

Merck’s Keytruda plus platinum- and fluoropyrimidine-based chemotherapy receives US FDA nod to treat certain patients with locally advanced/metastatic esophageal or GEJ carcinoma

Merck, known as MSD outside the United States and Canada, announced that the US Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, for the treatment of patients with locally advanced or metastatic esophageal or gastroesophageal junction (GEJ) (tumors with epicenter 1 to 5 centimeters above the GEJ) carcinoma that is not amenable to surgical resection or definitive chemoradiation in combination with platinum- and fluoropyrimidine-based chemotherapy. The approval is based on results from the phase 3 KEYNOTE-590 trial, which demonstrated significant improvements in overall survival (OS), progression-free survival (PFS) and objective response rate (ORR) for Keytruda plus fluorouracil (FU) and cisplatin versus FU and cisplatin alone, regardless of histology or PD-L1 expression status. For OS and PFS, Keytruda plus FU and cisplatin reduced the risk of death by 27% (HR=0.73 [95% CI, 0.62-0.86]; p<0.0001) and reduced the risk of disease progression or death...
Read more