Is vemurafenib FDA-approved?

On November 6, 2017, the Food and Drug Administration granted regular approval to vemurafenib (ZELBORAF, Hoffmann-La Roche Inc.) for the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation.

Table of Contents

What type of drug is vemurafenib?

Vemurafenib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

How does vemurafenib bind?

Vemurafenib is a competitive kinase inhibitor with activity against BRAF kinase with mutations like V600E. It exerts its function by binding to the ATP-binding domain of the mutant BRAF.

What is the mechanism of action of vemurafenib?

Vemurafenib is the first molecularly targeted therapy to be licensed in the US and Europe for treatment of advanced melanoma. Its mechanism of action involves selective inhibition of the mutated BRAF V600E kinase that leads to reduced signalling through the aberrant mitogen-activated protein kinase (MAPK) pathway.

When was vemurafenib approved by the FDA?

Vemurafenib targets BRAF V600E and was approved by the FDA in August 2011 for treating patients with melanoma positive for the BRAF V600E mutation after it was shown to improve survival for patients compared to dacarbazine, which was the standard treatment at the time.

When was Dabrafenib approved by the FDA?

On May 4, 2018, the Food and Drug Administration approved dabrafenib (TAFINLAR®, Novartis Pharmaceuticals Corp.) and trametinib (MEKINIST®, Novartis Pharmaceuticals Corp.)

Is vemurafenib chemotherapy?

Zelboraf® is the trade name for the generic chemotherapy drug vemurafenib. In some cases, health care professionals may use the generic name vemurafenib when referring to the trade name Zelboraf®. Drug type: Zelboraf® is a targeted therapy.

What does vemurafenib target?

Vemurafenib works to target melanoma cells with the goals of: Slowing the growth or spread of melanoma. Shrinking melanoma tumors.

How effective is vemurafenib?

Vemurafenib has prolonged efficacy in patients with BRAF V600–mutant NSCLC (n = 62), as demonstrated by a 37% overall response rate. Response rates were similar in previously treated and untreated patients.

Is dabrafenib FDA approved?

The Food and Drug Administration (FDA) recently approved the combination of the targeted drugs dabrafenib (Tafinlar) and trametinib (Mekinist) for the treatment of people with nearly any type of advanced solid tumor that has a specific mutation in a gene called BRAF.

Can dabrafenib cure melanoma?

Through clinical trials, cancer researchers have found that combining dabrafenib and trametinib can treat advanced melanoma more effectively than either medication on its own. The combination also produces less serious side effects than the single drugs used alone.

Is it better to be BRAF positive or negative?

We have demonstrated that BRAF positive patients receiving targeted treatment have significantly better survival than their BRAF negative counterparts.

Is vemurafenib a chemo?

Generic name: Vemurafenib

How long do you take ZELBORAF?

Take COTELLIC and ZELBORAF exactly as your healthcare provider tells you. Do not change your dose or stop taking COTELLIC and ZELBORAF unless your healthcare provider tells you to. Take COTELLIC one time a day for 21 days, followed by 7 days off treatment, to complete a 28-day treatment cycle.

Can dabrafenib cause bleeding?

This medicine may cause hemorrhage (severe bleeding) in the stomach and bowel areas or in the brain. Call your doctor right away if you have any unusual or unexplained bleeding. Dabrafenib may cause heart problems.

How long can you take dabrafenib?

You usually take dabrafenib twice a day, morning and evening, 12 hours apart. For advanced cancer, you take dabrafenib for as long as it is working and the side effects aren’t too bad. You take dabrafenib for up to 12 months if you are having it to try to prevent melanoma skin cancer coming back after surgery.

What does BRAF stand for in oncology?

BRAF (v-raf murine sarcoma viral oncogene homolog B1) is a serine/threonine protein kinase that plays a critical role in the RAS-RAF-MEK-ERK mitogen activated protein kinase (MAPK) cell signalling pathway.

What cancers have BRAF mutations?

These cancers include:

Melanoma (about half of all melanomas have the BRAF gene mutation)
Hairy cell leukemia.
Non-Hodgkin lymphoma.
Thyroid cancer.
Ovarian cancer.
Lung adenocarcinoma.
Colorectal cancer.
Certain brain cancers, including glioblastoma, pilocytic astrocytoma, and pediatric low-grade glioma.

What drug is used for hairy cell leukemia?

Cladribine and pentostatin are anticancer drugs commonly used to treat hairy cell leukemia.

What are the side effects of Zelboraf?

Common side effects of Zelboraf include:

joint pain,
tiredness,
nausea,
hair loss,
rash or itching,
skin growths (skin tags),
blurred vision,
increased sensitivity of your eyes to light,

Can dabrafenib cause melanoma?

Dabrafenib and trametinib increase the risk of skin cancer. Your doctor will check your skin before and during treatment. If a skin cancer develops it can usually be removed with surgery.

What foods to avoid if you have melanoma?

Avoid drinking large amounts of caffeinated beverages. Too much caffeine can lead to dehydration. Be observant of changes in bowel habits. Treatments for melanoma can often lead to changes in bowel habits including diarrhea, constipation, bloating, and gas.

What does it mean if you are BRAF positive?

“BRAF positive” means that your tumor has a mutation in the BRAF gene. This gene controls a protein that stimulates cell growth. When there’s a mutation, it causes the continuous production of this protein, which can lead to unchecked cell growth or cancer.

What does BRAF mean in medical terms?

BRAF is a human gene that encodes a protein called B-Raf. The gene is also referred to as proto-oncogene B-Raf and v-Raf murine sarcoma viral oncogene homolog B, while the protein is more formally known as serine/threonine-protein kinase B-Raf. BRAF. Available structures.

How long is chemo for hairy cell leukemia?

Pentostatin. Pentostatin given intravenously every other week for 3 to 6 months produces a 50% to 76% complete response rate and an 80% to 87% overall response rate.

Is vemurafenib FDA-approved?