Please login to the form below

Not currently logged in
Email:
Password:

Novartis' Afinitor sees positive trial results in breast cancer

Data indicating extended progression-free survival in women bring cancer drug closer towards new indication

Novartis moved a step close towards a lucrative breast cancer indication for its cancer drug Afinitor yesterday after reporting positive data from a phase III study.

Combination therapy based on Afinitor (everolimus) and Pfizer's anti-oestrogen drug Aromasin (exemestane) doubled progression-free survival in women with advanced breast cancer compared to Aromasin alone in the study, which presented at the San Antonio Breast Cancer Symposium.

Afinitor is already approved for advanced renal cell carcinoma and neuroendocrine tumours of pancreatic origin, but extending its indications in into breast cancer could add another 200,000 or more potential patients and $1bn to its peak sales potential. Novartis says it plans to file for approval in the new indication before the end of the year.

The drug brought in $310m for Novartis in the first nine months of the year, an 82 per cent increase over the same period of 2010.

The updated results of the BOLERO-2 study showed that Afinitor and Aromasin extended progression-free survival to 7.4 months in breast cancer patients, compared to 3.2 months with Aromasin alone.

Meanwhile, 12-month estimates of patients without disease progression were 31 per cent in the combination group and 10 per cent for Aromasin on its own.

"These data provide longer-term evidence of the benefit of adding everolimus to hormonal therapy in patients whose disease progressed while on or following initial hormonal treatment," commented Gabriel Hortobagyi of MD Anderson Cancer Centre in the US, the lead study author.

While there have been a multitude of new treatments for women with HER2-positive breast cancer in recent years, pharma pipelines have not been so generous for forms of the disease associated with other genetic mutations. BOLERO-2 enrolled patients who were HER2-negative but estrogen receptor-positive.

"Despite the significant progress in treating women with breast cancer, there have been no new treatment advances for women living with ER+HER2- advanced breast cancer in more than 15 years," said Hervé Hoppenot, president of Novartis Oncology.

"The results of BOLERO-2 are the first to show everolimus combined with hormonal therapy enabled women with this type of breast cancer to live significantly longer without their tumour progressing."

Novartis is also developing Afinitor for gastric cancer, HER2-positive breast cancer, hepatocellular carcinoma and lymphoma, and expects to file marketing applications in these indications from 2012 onwards.

9th December 2011

Share

PMEA Awards 2020

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Wilmington Healthcare

A heritage to envy Wilmington Healthcare brings together the data intelligence specialisms of Binley’s, NHiS, Wellards and HSJ to create...

Latest intelligence

#DemandDiversity: For International Women's Day, we ask... why do women often suffer from more side effects than men?
Women are largely prescribed exactly the same treatment regimens as men, with no account for the underlying differences in physiology and drug metabolism between the sexes....
Good design saves lives
Good design and creative thinking are essential if we are to improve on existing problems in new ways, which is why design and creativity within healthcare is vital. Health is...
Why you must understand the pricing of patient recruitment companies
Recruiting a diverse range of patients and engaging with them for your clinical trial isn’t an easy task, which means you might turn to patient recruitment companies, like us, who...

Infographics