Home Tags Posts tagged with "” skin disease ” ” post comment ”#q=” skin disease ” ” post comment ”"

” skin disease ” ” post comment ”#q=” skin disease ” ” post comment ”

Ordering Zelboraf
Zelboraf (vemurafenib) Tablets – Ordering


Find out more about ordering Zelboraf


Roche’s new drug Zelboraf (also known as PLX4032 and vemurafenib) was approved by the FDA on August 17th 2011 for treatment of melanoma patients whose tumors have BRAF mutations (new Zelboraf announcement order). Now that the drug has been approved, your doctor can prescribe it after determining that your tumor has this mutation.

In clinical trials with Zelboraf, patients’ tumors stopped growing for several months and patients were 63% less likely to die during the trial, as compared to those receiving chemotherapy.  Be sure to find out if Zelboraf is right for you before you order.

Zelboraf is being approved with a first-of-a-kind test called the cobas 4800 BRAF V600 Mutation Test, a companion diagnostic that will help determine if a patient’s melanoma cells have the BRAF V600E mutation.

The BRAF protein is normally involved in regulating cell growth, but is mutated in about half of the patients with late-stage melanomas. Zelboraf is a BRAF inhibitor that is able to block the function of the V600E-mutated BRAF protein.

“This has been an important year for patients with late-stage melanoma. Zelboraf is the second new cancer drug approved that demonstrates an improvement in overall survival,” said Richard Pazdur, M.D., director of the Office of Oncology Drug Products in the FDA’s Center for Drug Evaluation and Research. “In March, we approved Yervoy (ipilimumab), another new treatment for late-stage melanoma that also showed patients live longer after receiving the drug.”


What to know before you order? Zelboraf’s side effects.


The most common side effects reported in patients receiving Zelboraf included joint pain, rash, hair loss, fatigue, nausea, and skin sensitivity when exposed to the sun. About 26 percent of patients developed a skin-related cancer called cutaneous squamous cell carcinoma, which was managed with surgery. Patients treated with Zelboraf should avoid sun exposure. Patients that develop squamous cell carcinoma as a side effect of Zelboraf are treated by surgery and can continue with treatment

Zelboraf Drug Label Ordering: Ordering Zelboraf Drug Label (Original Ordering Zelboraf Drug Label on FDA’s website)


Use of ordered ZELBORAF and Important Side Effect Information for Zelboraf


This information does not take the place of talking to your doctor about your medical condition or your treatment with ZELBORAF.

ZELBORAF is a prescription medicine used to treat a type of skin cancer called melanoma, that has spread to other parts of the body or cannot be removed by surgery, and has a certain type of abnormal “BRAF” gene.

ZELBORAF may cause a type of skin cancer called cutaneous squamous cell carcinoma (cuSCC). CuSCC usually does not spread to other parts of the body. Check your skin and tell your doctor about skin changes including a new wart, a sore or bump that bleeds or does not heal, or a mole that changes size or color.

While taking ZELBORAF, you should avoid going out in the sun. When you go outside, wear clothes that protect your skin, including head, face, hands, arms, and legs. Use lip balm and a broad-spectrum sunscreen with SPF 30 or higher.

Possible serious side effects of ZELBORAF include severe allergic reactions, severe skin reactions, changes in the electrical activity of your heart called QT prolongation, which can potentially be life-threatening, abnormal liver function tests, eye problems, or new melanoma lesions.

Common side effects of ZELBORAF include joint pain, rash, hair loss, tiredness, sunburn or sun sensitivity, nausea, itching, or warts. You need to know these before ordering Zelboraf.

These are not all of the possible side effects of ZELBORAF. Tell your doctor if you have any side effect that bothers you or does not go away. For more information about side effects, ask your doctor or pharmacist.

Call your doctor for medical advice about any side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Genentech at 1-888-835-2555.

Please see accompanying full Prescribing Information and Medication Guide for additional important safety information.


How can you order Zelboraf?


With Zelboraf’s approval, your doctor can now prescribe this drug for you if your tumor has the BRAF mutation. To test the tumor, your doctor would order a laboratory test.

Several clinical trials are testing whether a combination of Zelboraf with other drugs might work better than Zelboraf alone. One exciting clinical trial combines Zelboraf with Yervoy, a new immunotherapy drug (Order more details about Zelboraf clinical trials). The following table lists some of these clinical trials that Zelboraf went through, and by clicking on the name of a trial you can learn more about the drug used and the types of patients that the trial is looking for.

Zelboraf Summary for Ordered Clinical Trials

Name(s) Target Manufacturer Status
Zelboraf, PLX4032, vemurafenib, RO5185426, RG7204 BRAF Hoffmann-La Roche Approved for melanoma patients with BRAF mutations


Zelboraf Clinical Trials Ordered


Trial Status Phase
A Study of the Effect of Food on the Pharmacokinetics of Single Dose RO5185426 And the Safety And Efficacy of Continuous Administration in Patients With BRAF V600E Mutation-Positive Metastatic Melanoma [NCT01264380] Recruiting ordered Phase I
Ph I/II Ipilimumab Vemurafenib Combo [NCT01400451] Not yet recruiting Phase I, Phase II
A Study of Vemurafenib in Metastatic Melanoma Patients With Brain Metastases [NCT01378975] Not yet recruiting Phase II
A Study of RO5185426 in Patients With Metastatic Melanoma [NCT01248936] Available Expanded access
A Study of RO5185426 in Comparison With Dacarbazine in Previously Untreated Patients With Metastatic Melanoma (BRIM 3) [NCT01006980] Recruiting ordered Phase 3
A Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma [NCT00949702] Active, not recruiting Phase 2
Safety Study of PLX4032 in Patients With Solid Tumors [NCT00405587] Active, not recruiting Phase 1
A Pharmacokinetic Study of RO5185426 in Combination With a Drug Cocktail in Patients With Metastatic Melanoma [NCT01001299] Active, not recruiting Phase 1
A Pharmacokinetic and Metabolism Study of 14C-labeled RO5185426 on Patients With Metastatic Melanoma [NCT01164891] Active, not recruiting Phase 1
A Pharmacokinetic/Pharmacodynamic Study of RO5185426 in Previously Treated Patients With Metastatic Melanoma [NCT01107418] Active, not recruiting Phase 1


In July 2011, the FDA issued a new draft guidance to facilitate the development and review of companion diagnostics. The guidance, currently available for public comment, is intended to provide companies with guidance on the agency’s policy for reviewing a companion diagnostic and the corresponding drug therapy.


Relevant Links for More Information on Zelboraf Ordering


Zelboraf Article Zelboraf Reference
Zelboraf for BRAF mutant melanoma Official website
FDA Approves Gene-Targeting Skin Cancer Drug NPR report
FDA appproves vemurafenib (ZELBORAF) for melanoma patients with BRAF mutations FDA announcement


Melanoma is the leading cause of death from skin disease. The National Cancer Institute estimated that 68,130 new cases of melanoma were diagnosed in the United States during 2010; about 8,700 people died from the disease.

Zelboraf is marketed by South San Francisco based-Genentech, a member of the Roche Group. The cobas 4800 BRAF V600 Mutation Test is manufactured by Roche Molecular Systems in Pleasanton, Calif.