FDA approves Stivarga for GIST

Familiar with GIST?
gastrointestinal stromal tumors
GIST

Today, the FDA announced the approval of Stivarga (regorafenib) to treat patients with advanced gastrointestinal stromal tumors (GIST) that cannot be surgically removed and no longer respond to other FDA-approved treatments for this disease.

Learn more here.

Health Equity Symposium: Science and Medicine in Africa

Don't miss the upcoming Health Equity Symposium: Science and Medicine in Africa

It has been a long standing challenge to help the developing world to battle disease, and while examples of progress have been made, including the eradication of smallpox, and the near eradication of polio, developing nations are still disproportionately burdened by infectious diseases that devastate lives and livelihoods, and put a continuous drag on struggling economies.

Some nations are making progress in public health, but a new unexpected burden of chronic, non-communicable diseases has emerged with changes in lifestyle and increasing life expectancies – including diabetes, cancer and asthma. Healthcare systems in these resource-limited regions are ill-prepared to deal with the long term needs of a population trying to treat and manage these conditions.

The symposium will focus on a new, more effective approach of increasing science and technology capabilities within the developing world. By building an infrastructure of research spaces, organizational capabilities, and a highly skilled workforce of scientists and clinicians, we ensure a path toward more sustainable, locally informed creative solutions.

Health Equity Symposium: Science and Medicine in Africa
February 28, 2013

Novartis - Auditorium
Novartis Institutes for BioMedical Research
250 Massachusetts Ave.
Cambridge, Massachusetts 02139

You can attend in person or virtually. Register and get more information here.

FDA approves Arcapta Neohaler to treat chronic obstructive pulmonary disease

The U.S. Food and Drug Administration today approved Arcapta Neohaler (indacaterol inhalation powder) for the long term, once-daily maintenance bronchodilator treatment of airflow obstruction in people with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema.

Health Equity Symposium

Novartis to host live webcast May 3-4 during inaugural Health Equity Symposium addressing the growing needs of diverse patient populations

* Dramatic shifts in the size of global, ethnic and regional populations are expected during the next 50 years
* Symposium will explore the biological foundations of health disparity and necessary steps to refocus pharmaceutical research to address these inequities
* Topics to include biases in research-design and portfolios, tissue banks, stem cell supplies, clinical studies and regulation

What: The Novartis Institutes for BioMedical Research (NIBR) is holding its inaugural Health Equity Symposium May 3-4, which will gather scientists, clinicians and policymakers to discuss what industry, academia and government can do to help shape the way biomedical research is conducted to better serve the unique needs of each group and ensure a more equitable delivery of health care.

Novartis Oncology Medical Information (Mobile)

This was originally published on MedicalSmartphones.com

There's a nice free medical app for oncology professionals that allows you to access Novartis Oncology Medical Information. They have apps for the iPhone, Android, and BlackBerry.  You can search for medical information and even submit a medical query.

Click here to learn more. (you have to be a licensed health care professional to access Novartis Oncology Medical Information.

Optimal treatment for CML (Chronic Myeloid Leukemia)

What's the optimal treatment for CML (Chronic Myeloid Leukemia)?  In the New England Journal of Medicine (NEJM), there were a few interesting articles this week that caught my attention:

• Dasatinib versus Imatinib in Newly Diagnosed Chronic-Phase Chronic Myeloid Leukemia
• Nilotinib versus Imatinib for Newly Diagnosed Chronic Myeloid Leukemia

Both of these studies were comparing imatinib (Gleevec) to newer drugs (dasatinib or Sprycel and nilotinib or Tasigna). In both cases, the newer agent appeared to result in better clinical responses (see conclusions below). If this is now the case, where does imatinib fall into treatment regimens for CML?  Who's going to want to receive Gleevec for their CML?

Conclusions: Dasatinib, administered once daily, as compared with imatinib, administered once daily, induced significantly higher and faster rates of complete cytogenetic response and major molecular response. Since achieving complete cytogenetic response within 12 months has been associated with better long-term, progression-free survival, dasatinib may improve the long-term outcomes among patients with newly diagnosed chronic-phase CML.

Conclusions: Nilotinib at a dose of either 300 mg or 400 mg twice daily was superior to imatinib in patients with newly diagnosed chronic-phase Philadelphia chromosome–positive CML.

Extavia (interferon beta-1b) approved for multiple sclerosis

Extavia (interferon beta-1b) has been approved by the FDA for the treatment of multiple sclerosis (MS). It's nice to have other options, right? This drug has been available in Europe, and now it's coming to the U.S.

Here are some interesting facts:

* Extavia is branded version of interferon beta-1b, a standard-of-care for multiple sclerosis in the US for more than 16 years

* MS affects around 400,000 people in US - one of the most common neurological disorders in young adults

* FDA approval marks important step forward for Novartis, laying foundation for innovative approach to treatment of MS

Here are the first few paragraphs from the press release:

Basel, August 17, 2009 - The US Food and Drug Administration (FDA) has approved Extavia® (interferon beta-1b), the first in a new planned portfolio of multiple sclerosis (MS) medicines from Novartis to help patients manage this devastating disease.

Extavia is approved by the FDA for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. The therapy is also indicated for patients who have experienced a first clinical episode of MS and have features consistent with the disease as shown by magnetic resonance imaging (MRI)[4].

The same medicinal product as Betaseron®*, Extavia offers patients and physicians a new branded version of interferon beta-1b, a first-line disease-modifying therapy that has been a standard-of-care for MS in the US for more than 16 years[1]. Extavia will be marketed by the Pharmaceuticals Division of Novartis.

"Interferon is a mainstay of treatment in MS," said Doug Jeffery, MD, Associate Professor at Wake Forest University Baptist Medical Center in Winston-Salem, North Carolina, USA. "With the approval of Extavia, patients have another option with a well-established safety and efficacy profile to help manage this disease."

MS is estimated to affect approximately 400,000 patients in the US[2], of whom more than 80% have relapsing-remitting MS[5]. MS is one of the most common causes of neurological disability in young adults. It is a chronic autoimmune disease in which the body's immune system attacks the myelin sheath, or protective tissue surrounding the nerve fibers that carry electrical signals in the brain[6]. The destruction of myelin causes problems with muscle control and strength, vision, balance, sensation and mental function[7].

I'm not listing the references, so if you want to view the entire press release, click here and you will go to the Novartis website.

In case you were wondering:

* Novartis gained the rights to seek approval for its own branded version of interferon beta-1b through agreements with Bayer Schering, the company that markets Betaseron.

Betaseron is marketed under the name of Betaferon® outside the US. Betaseron and Betaferon are registered trademarks of Bayer Schering Pharma AG.

Targeting Angiogenesis in Cancer

Anti-angiogenesis drugs work by blocking the activity of vascular endothelial growth factor (VEGF) to prevent the growth of new capillaries into the tumor and thereby sustain tumor growth. They have significantly changed the landscape of oncology because of their effectiveness and their associated toxicities. There have been several new biologic agents that have been approved and more are coming down the pipeline. Here are a few agents that come to mind:

• Avastin (bevacizumab) is a monoclonal antibody that inhibits angiogenesis and it was approved in 2004. In fact, it was the first agent approved by the FDA to inhibit angiogenesis. Avastin targets vascular endothelial growth factor (VEGF).
• Cediranib (tentative trade name Recentin), also known as AZD2171, is a potent inhibitor of vascular endothelial growth factor (VEGF) receptor tyrosine kinases.
• Vatalanib (PTK/ZK) is a small molecule tyrosine kinase inhibitor with broad specificity that targets all VEGF receptors (VEGFR), the platelet-derived growth factor receptor, and c-KIT.
• Sorafenib (Nexavar) is a multitargeted small molecule that inhibits VEGFR2, FLT3, PDGFR, and fibroblast growth factor receptor-1.
• The list goes on, but I'm going to stop here. This is a blog, not a medical review paper.

So why am I writing about these drugs? I'm curious: do you know who markets these drugs? Everyone probably knows Avastin (Genentech). What about Nexavar (Bayer/Onyx)? How about Recentin (AstraZeneca)? Vatalanib (Bayer Schering/Novartis).

It's exciting to see advances in cancer therapy, but in the spirit of recent healthcare reform discussions, I must ask, "who gets to decide how much (in terms of dollars) therapy a cancer patient should receive?" These biologic agents are very expensive and many patients are having tremendous difficulty paying for them. At what point does it make sense to deny coverage for therapy simply because it's too expensive? Never? I'm glad to I don't work in a managed care organization because these are some of the ethical issues that must get discussed on both an individual and a population level.

Novartis Produces First Batch of Swine Flu Vaccine

Novartis has produced a batch of experimental swine flu vaccine. Don't get your hopes up quite yet. The vaccine hasn't in been tested in humans yet. Instead of using eggs, this vaccine was deveoped using cell-based technology. In other words, the vaccine was made using cells, not eggs. I also heard that Baxter has completed testing and evaluation and is now in full-scale production of a commercial H1N1 vaccine using its Vero cell culture technology.

The WHO (Word Health Organization) is anticipating that swine flu (H1N1) vaccines should be ready and available by this fall. Let's hope that they are effective in controlling and reducing outbreaks this upcoming flu season as we face this pandemic.

Pfizer Oncology: Martine J. George, M.D., M.Sc

Pfizer announced the appointment of Martine J. George, M.D., M.Sc, to Vice President of Medical Affairs for its Oncology Business Unit. Dr. George received her M.Sc in Pharmacology from Montreal University and her M.D. from Paris University. Her industry experience includes companies like J&J, Ortho Biotech, Novartis, sanofi-aventis, and more.

Because the pharmaceutical industry is really an international business, there are opportunities even in the United States for foreign medical graduates (FMGs) / international medical graduates (IMGs). In order to climb the corporate ladder, you have to have strong business skills and excellent people skills. If you're an FMG or IMG interested in non-clinical opportunities, build your social network so that you can find the right types of opportunities.