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What is BIOMAb EGFR?

BIOMAb EGFR®, a humanized monoclonal antibody falls under a class of cancer treatment option known as targeted therapy.
Targeted cancer therapies interfere with cancer cell growth and division in different ways and at various points during the development, growth, and spread of cancer. They target molecules specific to cancer cells and prevent the cancerous cells from growing, dividing and spreading uncontrollably.

BIOMAb EGFR® (Nimotuzumab) is also known by the brand names Theracim, Theraloc, etc., in different countries where it is approved.

BIOMAb EGFR® is currently approved for treatment of head and neck cancers in India, Cuba, Argentina, Colombia, Ivory Coast, Gabon, Ukraine, Peru, Vietnam and Sri Lanka; for glioma (pediatric and adult) in Cuba, Argentina, the Philippines, Myanmar, Mexico, Indonesia, Switzerland, Vietnam, Brazil and Ukraine; for nasopharyngeal cancer (a type of head and neck cancer) in China. It has been granted orphan drug status for Glioma in the USA and for Glioma and pancreatic cancer in Europe. A number of clinical trials are being conducted worldwide to evaluate the efficacy of this molecule in various other indications also like lung cancer, pancreatic cancer, cervical cancer etc.

How does BIOMAb EGFR® work?
BIOMAb EGFR® targets the epidermal growth factor receptor (EGFR) present on the cell surface. The binding of certain growth factors to this receptor starts a series of events that are essential for cell growth, differentiation, and survival (both normal and cancerous). In cancerous cells there is an over expression of EGFR leading to uncontrolled cell growth, proliferation, survival and creation of new blood vessels. A very high level of EGFR is seen in many solid tumors and has been associated with poor treatment outcomes. BIOMAb EGFR® binds to the site on EGFR where the growth factors are supposed to bind and thus prevents cancer cells from proliferating, making new blood vessels and evading death. BIOMAb EGFR® also helps the body's immune system in recognizing the cancerous cells and fighting against them.

Are there any serious side effects of BIOMAb EGFR®?
Based on the experience of thousands of patients, BIOMAb EGFR® remains to be the unique monoclonal antibody of its class that has rarely exhibited any severe skin rashes till date.
Studies conducted worldwide prove that BIOMAb EGFR® has a very good safety profile. In an Indian study of 92 patients with head and neck cancer, there have not been any incidences of severe skin rashes, hypomagnesaemia (low magnesium count) and other classical EGFR inhibition related side effects.

In over 9,000 patients worldwide and over 3000 patients treated in India, there have rarely been any toxicities which are usually frequently reported with other EGFR targeting agents. The common side effects that have been observed with BIOMAb EGFR® are chills, rigors, nausea and very minor rashes.

What makes BIOMAb EGFR® different from other cancer treatments?
Efficacy without associated toxicities is an important feature which differentiates BIOMAb EGFR® from other targeted therapies against EGFR.

The superior safety profile of BIOMAb EGFR® can be attributed to its proven unique molecular profile leading to its rapid clearance from normal cells, high tumor selectivity and specificity and its ability to enhance the antitumor effects of radiotherapy and chemotherapy.

BIOMAb EGFR® has been seen to bind strongly to the tumor cells with high EGFR expression whereas in normal cells with low EGFR expression the binding is temporary or negligible. Unlike other EGFR inhibitors, there are negligible incidences of debilitating skin rashes, hypomagnesaemia or any other such side effects with BIOMAb EGFR® treatment.

About Head & Neck Cancer:

Understanding Head & Neck Cancer:

The term Head and Neck cancer refers to a group of biologically similar cancers originating from the upper aerodigestive tract, including the lip, oral cavity (mouth), nasal cavity, paranasal sinuses, pharynx, and larynx. Most Head and Neck cancers are squamous cell carcinomas, originating from the mucosal lining (epithelium) of these regions.

Prevention is better than cure:
Cancer prevention is action taken to lower the chances of getting cancer. By preventing cancer, the number of new cases of cancer in a group or population can be lowered and which eventually, can help reduce the number of deaths caused by cancer.

Some risk factors of cancer can be avoided, but many cannot. For example smoking, tobacco chewing and inheriting certain genes are risk factors for certain kinds of cancer, but of the three, smoking and tobacco chewing can be avoided. Regular exercise and a healthy diet can prove to be protective factors for certain kinds of cancer.

Different ways to prevent cancer are being studied, including:

  • Changing lifestyle or eating habits
  • Avoiding things known to cause cancer
  • Taking medicines to treat a precancerous condition or to prevent the start of cancer

Risk factors for Head & Neck cancer:

Common Causes:
Tobacco (including smokeless tobacco, sometimes called “chewing tobacco” or “snuff”) and alcohol are the most common risk factors of head & neck cancers, particularly those of the oral cavity, oropharynx, hypopharynx, and larynx.  Eighty-five percent  of head & neck cancers are linked to tobacco use. People who use both tobacco and alcohol are at a greater risk of developing these cancers than those who use either tobacco or alcohol.

Other risk factors of cancers of the head & neck:

  • Oral cavity: Sun exposure(lip); possibly human papillomavirus (HPV) infection.
  • Salivary glands: Radiation to the head and neck. This exposure can come from diagnostic x-rays or from radiation therapy for noncancerous conditions or cancer.
  • Paranasal sinuses and nasal cavity: Certain industrial exposures, such as wood or nickel dust inhalation. Tobacco and alcohol use may play less of a role in this type of cancer.
  • Nasopharynx: Asian, particularly Chinese, ancestry; Epstein-Barr virus infection; occupational exposure to wood dust; and consumption of certain preservatives or salted foods.
  • Oropharynx: Poor oral hygiene; HPV infection and the use of mouthwash that has high alcohol content are possible, but not proven, risk factors.
  • Hypopharynx: iron and other nutritional deficiencies.
  • Larynx: Exposure to airborne particles of asbestos, especially in the workplace.

South Asians who chew ‘paan’ (betel quid) may be aware that this habit has been strongly associated with an increased risk of oral cancer. Also, consumption of mate, a tea-like beverage, habitually consumed by South Americans, has been associated with an increased risk of cancers of the mouth, throat, esophagus, and larynx.

People who are at risk of head & neck cancers should consult their doctor about ways of reducing their risk. They should also discuss how often to have checkups.

Symptoms of Head & Neck Cancer:

Symptoms of several head & neck cancer sites include a lump or sore that does not heal, a sore throat that does not go away, difficulty in swallowing, and a change or hoarseness in the voice. Other symptoms include the following:

  • Oral cavity: A white or red patch on the gums, tongue, or lining of the mouth; a swelling of the jaw that causes dentures to fit poorly or become uncomfortable; and unusual bleeding or pain in the mouth.
  • Nasal cavity and sinuses: Sinuses that are blocked and do not clear, chronic sinus infections that do not respond to treatment with antibiotics, bleeding through the nose, frequent headaches, swelling or other trouble with the eyes, or pain in the upper teeth.
  • Salivary glands: Swelling under the chin or around the jawbone; numbness or paralysis of the muscles in the face; or pain that does not go away in the face, chin, or neck.
  • Oropharynx and hypopharynx: Ear pain.
  • Nasopharynx: Trouble breathing or speaking, frequent headaches, pain or ringing in the ears, or trouble hearing.
  • Larynx: Pain when swallowing, or ear pain.
  • Metastatic squamous neck cancer: Pain in the neck or throat that does not go away.

These symptoms may be caused by cancer or by other, less serious conditions. It is important to consult a doctor or dentist with regard to any of these symptoms.

Diagnosis of Head & Neck Cancers:

To find the cause of symptoms, the doctor evaluates a person's medical history, performs a physical examination, and orders diagnostic tests. The examinations or tests conducted may vary, depending on the symptoms. Examination of a sample of tissue under the microscope is always necessary to confirm a diagnosis of cancer.

Some examination / tests that may be useful are described below:

  • Physical examination may include visual inspection of the oral and nasal cavities, neck, throat, and tongue, using a small mirror and/or lights. The doctor may also feel for lumps on the neck, lips, gums, and cheeks.
  • Endoscopy is the use of a thin, lighted tube called an endoscope to examine areas inside the body. The type of endoscope the doctor uses depends on the area being examined. For example, a laryngoscope is inserted through the mouth to view the larynx; an esophagoscope is inserted through the mouth to examine the esophagus.
  • Laboratory tests examine samples of blood, urine, or other substances from the body.
  • X-rays create images of areas inside the head and neck on film.
  • CT or CAT scan is a series of detailed pictures of areas inside the head and neck created by a computer linked to an x-ray machine.
  • Magnetic Resonance Imaging (or MRI) examines detailed pictures of areas inside the head and neck.
  • PET scan uses sugar that is modified in a specific way so that it is absorbed by cancer cells and appears as dark areas on the scan.
  • Biopsy is the removal of tissue. A pathologist studies the tissue under a microscope to make a diagnosis. A biopsy is the only sure way to tell whether a person has cancer.

Treatment for Head & Neck Cancer:
Surgery: The surgeon may remove the cancer and some of the healthy tissue around it. Lymph nodes in the neck may also be removed (lymph node dissection) if the doctor suspects that the cancer has spread. Surgery may be followed by radiation treatment.

Head and neck surgery often changes the patient's ability to chew, swallow, or talk. The patient may look different after surgery, and the face and neck may be swollen. The swelling usually goes away within a few weeks. However, lymph node dissection can slow the flow of lymph, which may collect in the tissues; this swelling may last for a long time. After a laryngectomy (surgery to remove the larynx), parts of the neck and throat may feel numb because nerves have been cut. If lymph nodes in the neck are removed, the shoulder and neck may be weak and stiff. Patients should report any side effects to their doctor or nurse, and discuss what approach to take.

Radiation therapy: also called radiotherapy. This treatment involves the use of high-energy x-rays to kill cancer cells. Radiation may come from a machine outside the body (external radiation therapy). It can also come from radioactive materials placed directly into or near the area where the cancer cells are found (internal radiation therapy or radiation implant).

In addition to its desired effect on cancer cells, radiation therapy often causes unwanted effects. Patients who receive radiation to the head and neck may experience redness, irritation, and sores in the mouth; a dry mouth or thickened saliva; difficulty in swallowing; changes in taste; or nausea. Other problems that may occur during treatment are loss of taste, which may decrease appetite and affect nutrition, and earaches (caused by hardening of the ear wax). Patients may also notice some swelling or drooping of the skin under the chin and changes in the texture of the skin. The jaw may feel stiff and patients may not be able to open their mouth as wide as before treatment. Patients should report any side effects to their doctor or nurse and ask how to manage these effects.

Chemotherapy: also called anticancer drugs. This treatment is used to kill cancer cells throughout the body. The side effects of chemotherapy depend on the drugs that are given. In general, anticancer drugs affect rapidly growing cells, including blood cells that fight infection, cells that line the mouth and the digestive tract, and cells in hair follicles. As a result, patients may have side effects such as lower resistance to infection, sores in the mouth and on the lips, loss of appetite, nausea, vomiting, diarrhea, and hair loss. They may also feel unusually tired and experience skin rash and itching, joint pain, loss of balance, and swelling of the feet or lower legs.

Targeted Therapies
The term "targeted therapy" refers to newer generation of cancer drugs designed to block the growth of cancer cells by interfering with specific molecules involved in tumor growth and proliferation. Most targeted therapies are either small-molecule drugs or monoclonal antibodies. Small-molecule drugs act on targets that are found inside the cell. Monoclonal antibodies, on the other hand, are directed against targets outside cells or on the cell surface. Due to their target specific action, targeted therapies are more effective, and safer than conventional cytotoxic chemotherapy.

BIOMAb EGFR® is humanized monoclonal antibody, a targeted therapy approved in India for treatment of Head and Neck cancers. It selectively binds to the Epidermal Growth Factor Receptor present on the tumor cell surface, thus preventing tumor growth, proliferation and metastasis.
Efficacy without associated toxicities is an important feature which differentiates BIOMAb EGFR® from other targeted therapies against EGFR.



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