Ordering Zelboraf

 

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)

 

 

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.