FDA Approval History: Tazverik 2020 New Drug

Approval History of Tazverik

FDA Approved approved Tazverik on 23 January 2020.

Name of brand: Tazverik

Type of dosage: tablets

Generic Name of Tazverik is Tazemetostat

EZM 200 (200 mg tazverik) Pill with EZM 200 imprint is red, round and marked as 200 mg Tazverik. This is manufactured by Epizyme, Inc.

Tazverik is used for epithelioid sarcoma treatment; follicular lymphoma and belongs to the class of medication miscellaneous antineoplastic. Tazverik 200 mg is not a Controlled Substances Act (CSA) drug.

What exactly is TAZVERIK?

TAZVERIK is a generic pharmaceutical drug used for treatment:

Tazverik (tazemetostat) is a methyltransferase inhibitor that is used to treat:

Adults and juvenile patients 16 years of age and older not recommended for complete resection of metastatic or locally advanced epithelioid sarcoma;

Adult patients with relapsed or refractory follicular lymphoma whose tumors are responsive to an EZH2 mutation as identified by an FDA-approved examination and who have undergone at least 2 previous systemic therapies.

Adult patients with follicular lymphoma rebound or refractory who have no appropriate viable treatment choices.

TAZVERIK approval in these patients is based on trials that calculated the percentage of patients following therapy whose tumor shrank or simply disappeared, and how long the reaction lasted. Further validate those advantages, TAZVERIK is still being tested.

It is not known if TAZVERIK would be healthy and successful in children under the age of 16 years.

What is the Advantage of TAZVERIK?

For the 62 TAZVERIK patients, 9 patients (15%) experienced partial or full cancer shrinkage. The shrinkage lasted six months or more for six of these cases (67%).

TAZVERIK has been approved under the accelerated approval plan of the FDA which offers earlier patient access to a potential new medication as the company continues to perform clinical trials to validate and further evaluate the therapeutic value.

IMPORTANT INFORMATION SAFETY :

What's the most important detail about TAZVERIK that I would know?

TAZVERIK can lead to serious side effects including:

Chance of developing new cancers. The rise in new (second) cancers has emerged in people who sought TAZVERIK treatment. Speak to the healthcare professional about the chance to contract new cancer. The health-care professional will check you for new cancers, During/After the TAZVERIK diagnosis. When you feel more exhausted than normal, notify the healthcare provider, or have quick bruising, fever, bone pain, or paleness.

Tell your health care professional about all of your medical problems before taking TAZVERIK, even if you:

Are pregnant or have plans to get pregnant. TAZVERIK has the power to hurt your unborn child. Once you begin therapy with TAZVERIK the health care provider will give you a pregnancy check. When you are pregnant or suspect you might be pregnant, tell the healthcare provider straight away.

Females who may get pregnant will use appropriate non-hormonal birth control (such as condoms) during care and for 6 months after TAZVERIK 's final dosage. Where used during TAZVERIK therapy, birth control pills (oral contraceptives) and other hormonal methods of birth control may not be effective. Talk to the healthcare provider about options for birth control which are best for you.

Males with female partners who are likely to get pregnant will be given adequate fertility control during therapy and for 3 months following the final dose of TAZVERIK.

Are breastfeeding, or are preparing to breastfeed. This is not clear whether TAZVERIK moves into your breast milk. Should not breastfeed during therapy except for one week after the final dose of TAZVERIK.

Inform the healthcare professional about all the medications you are taking, including prescribed and over-the-counter drugs,vitamins and herbal supplements. TAZVERIK can affect the way other medicines function and other medicines that affect the way TAZVERIK works.

What should I avoid during Treatment with TAZVERIK?

During therapy with TAZVERIK, stop consuming grapefruit or drinking grapefruit juice.

Consult to the healthcare provider before taking any new drugs or supplements.

TAZVERIK Dosing:

General Adult Dose for Soft Tissue Sarcoma:

800 mg orally 2 times daily without disease development or excessive toxicity.

Use: For the treatment of adult patients with metastatic or locally advanced epithelioid sarcoma who are not suitable for full resection.

General Pediatric Dose for Soft Tissue Sarcoma:

16 years of age and older:

800 mg orally 2 times daily without disease development or excessive toxicity.

Use: In the care of pediatric patients 16 years of age and over with metastatic or locally advanced epithelioid sarcoma not suitable in full resection.

Indications and Application of Tazverik :

Sarcoma, Epithelioid

Tazverik is recommended for the care of adults and pediatric patients 16 years of age and older with metastatic or locally advanced epithelial sarcoma who are not suitable for full resection.

This diagnosis is approved for accelerated regulation on the basis of an average reaction rate and length of treatment [see Clinical Studies. Continued clearance for this indication may depend on the evaluation and explanation of the clinical advantage in a confirmatory trial(s).

Relapse or Refractory Follicular Lymphoma :

Tazverik is recommended for the treatment of adult patients with relapsed or refractory (R / R) follicular lymphoma (FL) whose tumors are positive for the EZH2 mutation as observed in the FDA-approved study and who have undergone at least 2 previous systemic therapies.

Tazverik is recommended for the treatment of adult patients with R / R FL who do not have appropriate available care choices.

Such indications are approved under accelerated approval on the basis of the average response rate and length of response The continued acceptance of these indications the depend on the evaluation and definition of the clinical advantage in the confirmatory test(s).

Possible side effects of TAZVERIK?

Get emergency medical treatment if you have symptoms of an allergic reaction to Tazverik: hives; trouble breathing; swelling of your face, lips,  tongue, or throat.

Contact your doctor as soon if you have:

The most common side effects of TAZVERIK in people with epithelial sarcoma include:

Stress

sleepiness

Nausea's

Reduced Hunger

Vomiting

Constipation 

The most common side effects of TAZVERIK in patients with follicular lymphoma are:

Tiredness and fatigue

Cold-like signs (upper respiratory infection)

Body Pain

Nausea's

Pain in the stomach (abdominal)

Those are not aware of the potential side effects of TAZVERIK.

Contact the doctor for professional advice on side effects. You should report adverse effects to the FDA at 1-800-FDA-1088.

Drug Drug Interaction of Tazverik?

Sometimes it is not safe to use certain drugs at the same time. Some medications may affect the blood levels of other medicines you take, which can increase side effects or make the treatment less effective.

Certain medicines that interact with tazemetostat, including prescription and over-the-counter medications, vitamins, and herbal products. Tell the doctor of all the existing medications and any drugs you continue or avoid taking.