Oncology, Drugs

Avastin, An Angiogenesis Inhibitor

Avastin 400 mg

Bevacizumab with the trade name Avastin was the first available angiogenesis inhibitor in the United States. It is a “Monoclonal Antibody” and “Anti-Angiogenesis” drug used to treat a number of types of cancers by interfering with the growth and spread of cancer cells in the body and it is also used for specific eye diseases.

Avastin injection is used to treat wet age-related macular degeneration. According to the World Health Organization’s List of Essential Medicines, Bevacizumab is the most effective and safe medicine needed in a health system.

Avastin price is around $842 for a supply of 4 milliliters and nearly 6,500 people per year could be eligible for the drug. Generalized Weakness and Pain are the common Avastin side effects that occur in greater than 30% of patients taking this drug.

History

In 1971, Judah Folkman hypothesized that stopping angiogenesis might be useful in controlling cancer growth. Later, scientist  Napoleone Ferrara in the laboratory of Genentech worked on the discovery of the Human Vascular Endothelial Growth Factor (VEGF); VEGF is a protein that stimulated blood vessel growth.

At the end of the study, Ferrara found out that antibodies against VEGF inhibit tumor growth in mice and validated the hypothesis of Judah Folkman. This study was the base of Bevacizumab development.

In 2004: It was approved in the United States  for combination use with standard chemotherapy for metastatic colon cancer

In 2006: FDA Approves Avastin in Combination With Chemotherapy for First-Line Treatment of Most Common Type of Lung Cancer

In 2008: FDA approved bevacizumab for breast cancer subject to further studies.  But after further study, The FDA’s advisory panel had recommended against approval.

In 2009: FDA Grants Accelerated Approval of Avastin for Brain Cancer (Glioblastoma) that Has Progressed Following Prior Therapy

In 2011: Genentech requested a hearing granted in June 2011. The FDA ruled to withdraw the breast cancer indication in November 2011. Genentech required the FDA approval to market a drug for that indication.

In 2017: The FDA Granted Genentech’s Avastin Full Approval for the Most Aggressive Form of Brain Cancer.

The patents on Avastin will expire in the US in 2019 and in Europe in 2022 after that we predict more Avastin suppliers around the world.

Medical Uses

Bevacizumab is approved to be used alone or with other drugs to treat:

  • Patients with persistent, recurrent, or metastatic cervical cancer
  • Patients with stage III or IV epithelial ovarian, fallopian tube, or primary peritoneal cancer following initial surgical resection
  • Patients with platinum-resistant recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who received no more than 2 prior chemotherapy regimens
  • Metastatic renal cell carcinoma
  • Patients with unresectable, locally advanced, recurrent, or metastatic non–squamous non–small cell lung cancer
  • Recurrent glioblastoma in adults.
  • Patients with metastatic colorectal cancer who have progressed on a first-line Avastin-containing regimen.

It is not indicated for the adjuvant treatment of colon cancer. It is also being studied for the treatment of other types of cancer.

If you are looking for a Turkish pharmaceutical distributor for your Avastin inquiry please contact Dano Health Group.

Mechanism

In the case of bevacizumab, a recombinant humanized monoclonal antibody, the mechanism of action is inhibition of a cell surface protein called vascular endothelial growth factor (VEGF). The function of VEGF is to help tumors to form new blood vessels; blocking VEGF stops cancer from developing its own blood supply.

So that tumor’s supply of oxygen and nutrients will be reduced and the growth and survival of tumors will be stopped. Angiogenesis inhibitors or anti-angiogenic are terms used for drugs preventing the growth of blood vessels. According to the preclinical models, Avastin directly binds Vascular Endothelial Growth Factor (VEGF) to inhibit angiogenesis.

Avastin

These models have shown that this drug may have certain effects to inhibit tumor growth and development:

Proposed effectsPotential effect on vesselsPotential impact on tumor
Anti-vascularRegression of existing tumor vasculatureReduction of tumor size
Anti-angiogenesisInhibition of new and recurrent tumor vessel growthInhibition of tumor growth

Biosimilar

In July 2014, two pharming companies, PlantForm, and PharmaPraxis as a clinical trial product distributor in collaboration with the Fraunhofer Center for Molecular Biology announced their plans to commercialize a biosimilar version of bevacizumab made by the use of a tobacco expression system.

Biotech giant Amgen and partner Allergan produced Mvasi, Bevacizumab biosimilar. In 2017 Amgen’s biosimilar (generic name bevacizumab-Awwb, product name Mvasi) was approved by the US FDA for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube, or primary peritoneal cancer and carcinoma of the cervix.

Biocon and partner Mylan have a version under review in the EU. Manufacturers including Samsung Bioepis, Boehringer Ingelheim, Pfizer, AryoGen Biopharma, Reliance Life Sciences, and Fujifilm Kyowa Kirin Biologics have Avastin biosimilars in phase 3.

Global Market

The second leading cause of mortality among cancer patients in the world is Colorectal cancer (CRC); It is also the third most diagnosed cancer globally and thus represents a huge burden on healthcare systems. Avastin claimed its first approval in colorectal cancer in 2004 and has steadily added new indications since then and recently approved by European to use alongside Tarceva for patients with EGFR-positive non-small cell lung cancer.

According to the new PharmaPoint Drug Evaluation report of GlobalData, currently, Avastin is Roche’s second biggest-selling drug and routinely swapping places with breast cancer stalwart Herceptin. Next year, the combination of Avastin plus Tecentriq could be submitted to regulators if studies in renal cell carcinoma and non-small cell lung cancer go according to plan.

Due to rising demand for ovarian, colorectal, lung, and cervical cancer, particularly in Europe and emerging markets, this drug’s sales rose 9% in 2015.  But its upward trajectory is likely to change because biosimilar versions of the drug are hitting the market. These biosimilars are already on the market, notably in India and Russia but they will have a fight on their hands with Roche.

Roche has patent protection for Avastin in the U.S. until 2019 and in Europe until 2022. Avastin is marketed in Turkey under the trade name Altuzan. EvaluatePharma is only expecting the brand to lose a couple of billion dollars by 2022 but keeping it among the top 10 cancer drugs.

Pouria Akhzary

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