Tukysa | European Medicines Agency (2024)

Overview

Tukysa is a cancer medicine that is used to treat breast cancer that is locally advanced or metastatic (has spread to other parts of the body) and when it is HER2-positive. This means the cancer cells produce a protein on their surface, HER2, which stimulates the growth of the cancer.

Tukysa is used with two other medicines, capecitabine and trastuzumab, and is used after at least 2 other treatments for HER2-positive cancer have already been tried.

The active substance in Tukysa is tucatinib.

Tukysa can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in giving cancer treatments. It is given by mouth in a recommended dose of 300mg twice a day. Patients are also treated with capecitabine and trastuzumab on certain days of a 21-day cycle.

Treatment can continue as long as the cancer does not get worse and side effects are bearable. The doctor may recommend a reduced dose of Tukysa if certain side effects occur, or may stop treatment temporarily or permanently.

For more information about using Tukysa, see the package leaflet or contact your doctor.

The active substance in Tukysa, tucatinib, is a type of cancer medicine called a tyrosine kinase inhibitor. It attaches to the HER2 protein on the cancer cells, and so blocks its action. Because HER2 helps cancer cells to grow and divide, blocking it helps to stop these cells growing and causes them to die, controlling the growth of the cancer.

Tukysa has been shown to improve the length of time that patients with advanced or metastatic HER2-positive breast cancer lived without their disease getting worse. In an ongoing main study involving 612 such patients whose disease had got worse after previous treatments or in whom other treatments were unsuitable, Tukysa was compared with placebo (a dummy treatment) when added to two other cancer medicines, trastuzumab and capecitabine.

When the results were analysed, the average length of time that patients lived without their disease getting worse was 7.8 months with Tukysa and 5.6 months with placebo. Overall, around 41% of patients given Tukysa and 23% given placebo showed some response to treatment and the two groups lived on average about 22 months and 17 months respectively. Responses to Tukysa were comparable in the subgroup of patients whose cancer had spread to the brain.

The most common side effects with Tukysa (which may affect more than 1 in 10 people) are nose bleeds, diarrhoea, nausea (feeling sick), vomiting, stomatitis (inflammation of the mouth), rash, arthralgia (joint pain), increases in the blood levels of liver enzymes ALT and AST (a sign of potential liver problems) and in bilirubin, and weight loss. The most common serious side effects with Tukysa (which may affect more than 1 in 20 people) are diarrhoea and increased ALT and AST; nausea and vomiting may also be serious.

For the full list of side effects and restrictions with Tukysa, see the package leaflet.

The European Medicines Agency noted that the evidence showed an improvement in survival with Tukysa in a group of patients who had few alternative options. The company would need to provide final results of the main study to clarify the exact extent of the benefits. The reported side effects were considered manageable, and mostly related to effects on the gut. The Agency therefore decided that Tukysa’s benefits are greater than its risks and it can be authorised for use in the EU.

The company that markets Tukysa will provide final results from the main study showing the length of time patients live overall as well as without their disease getting worse.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Tukysa have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Tukysa are continuously monitored. Side effects reported with Tukysa are carefully evaluated and any necessary action taken to protect patients.

Tukysa received a marketing authorisation valid throughout the EU on 11 February 2021.

Tukysa : EPAR - Medicine overview

First published: 18/02/2021Last updated: 18/02/2021Reference Number: EMA/50289/2021

English (EN) (119.14 KB - PDF)

View

Other languages (22)

български (BG) (134.18 KB - PDF)

View

español (ES) (109.27 KB - PDF)

View

čeština (CS) (132.98 KB - PDF)

View

dansk (DA) (109.14 KB - PDF)

View

Deutsch (DE) (113.15 KB - PDF)

View

eesti keel (ET) (97.01 KB - PDF)

View

ελληνικά (EL) (133.46 KB - PDF)

View

français (FR) (110.85 KB - PDF)

View

hrvatski (HR) (131.19 KB - PDF)

View

italiano (IT) (108.39 KB - PDF)

View

latviešu valoda (LV) (137.4 KB - PDF)

View

lietuvių kalba (LT) (129.59 KB - PDF)

Product information

Tukysa : EPAR - Product information

First published: 18/02/2021Last updated: 21/08/2023

English (EN) (505.81 KB - PDF)

View

Other languages (24)

български (BG) (485.52 KB - PDF)

View

español (ES) (445.12 KB - PDF)

View

čeština (CS) (462.22 KB - PDF)

View

dansk (DA) (424.38 KB - PDF)

View

Deutsch (DE) (452.06 KB - PDF)

View

eesti keel (ET) (445.14 KB - PDF)

View

ελληνικά (EL) (503.24 KB - PDF)

View

français (FR) (484.02 KB - PDF)

View

hrvatski (HR) (457.37 KB - PDF)

View

íslenska (IS) (423.53 KB - PDF)

View

Product details

Name of medicine

Tukysa

Active substance

Tucatinib

International non-proprietary name (INN) or common name

tucatinib

Therapeutic area (MeSH)

Breast Neoplasms
Neoplasm Metastasis

Anatomical therapeutic chemical (ATC) code

L01EH03

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Tukysa is indicated in combination with trastuzumab and capecitabine for the treatment of adult patients with HER2?positive locally advanced or metastatic breast cancer who have received at least 2 prior anti?HER2 treatment regimens.

Authorisation details

EMA product number: EMEA/H/C/005263
Additional monitoring: This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.
Marketing authorisation holder: Seagen B.V.
Evert Van De Beekstraat 1/104
1118 CL Schiphol
Netherlands
Opinion adopted: 10/12/2020
Marketing authorisation issued: 11/02/2021
Revision: 5

Tukysa | European Medicines Agency (2024)

FAQs

How effective is Tukysa? ›

39.7% (135 out of 340) of people saw their tumors shrink with TUKYSA* vs 21.6% (37 out of 171) of people treated with trastuzumab and capecitabine alone; 0.9% (3 of 340) of people had their tumors completely disappear (complete response) with TUKYSA* vs 1.2% (2 of 171) of people treated with trastuzumab and ...

Tell Me More ›

Is Tukysa FDA approved? ›

Tucatinib (Tukysa) and trastuzumab (Herceptin) are now approved by FDA to treat some people with colorectal cancer whose tumors produce an excess of HER2 proteins.

Keep Reading ›

What is the ATC code for Tukysa? ›

The active substance of Tukysa is tucatinib, an antineoplastic protein kinase inhibitor (ATC code: L01EH03) which inhibits HER2 kinase.

Get More Info ›

How much does Tukysa cost? ›

The cost for Tukysa oral tablet 150 mg is around $13,504 for a supply of 60 tablets, depending on the pharmacy you visit. Quoted prices are for cash-paying customers and are not valid with insurance plans. This price guide is based on using the Drugs.com discount card which is accepted at most U.S. pharmacies.

Tell Me More ›

Is there a generic for Tukysa? ›

Tukysa generic

Tukysa is available only as a brand-name medication. It's not currently available in generic form. (A generic drug is an exact copy of the active drug in a brand-name medication.)

Know More ›

When was Tukysa FDA approved? ›

On January 19, 2023, the Food and Drug Administration (FDA) granted accelerated approval to tucatinib (Tukysa, Seagen Inc.)

Show Me More ›

Where is Tukysa manufactured? ›

ESTEVE is producing the Active Pharmaceutical Ingredient of Tukysa®, which has been approved by the Food and Drug Administration (FDA) in April of 2020 1 in its FDA-approved, cGMP, multipurpose facility in Spain.

Discover More Details ›

What is the duration of treatment for Tukysa? ›

The median duration of treatment was 5.8 months (range: 3 days, 2.9 years) for the TUKYSA arm. Serious adverse reactions occurred in 26% of patients who received TUKYSA.

Read The Full Story ›

What class of drug is Tukysa? ›

Generic Name: tucatinib

Tucatinib belongs to a class of drugs known as kinase inhibitors. It works by slowing or stopping the growth of cancer cells.

Tell Me More ›

What is ATC drug code? ›

The Anatomical Therapeutic Chemical code: a unique code assigned to a medicine according to the organ or system it works on and how it works.

Learn More Now ›

Do ATC codes change? ›

A few alterations in ATC codes and DDDs usually occur annually and new ATC codes and DDDs are introduced every year. Thus it is necessary to check for updates in the drug list regularly: updates of the ATC/DDD Index are issued in January each year.

Read On ›

What is L01E ATC code? ›

L01E PROTEIN KINASE INHIBITORS

This group comprises protein kinase inhibitors used for neoplastic diseases. Substances are classified according to their main target. Substances which are multi-targeted without a clear main target are classified in L01EX.

Who can dispense Tukysa? ›

In most cases, your TUKYSA (tucatinib) prescription will be filled in 1 of the following ways:

Your healthcare provider may send your prescription to a specialty pharmacy; or.
There may be a pharmacy at your healthcare provider's office or hospital that can fill your prescription for pickup or delivery to your home.

Tell Me More ›

What is the other name for Tukysa? ›

Tucatinib is one of a group of cancer drugs called tyrosine kinase inhibitors (TKIs). Tucatinib is the drug's non-branded name. Its brand name is Tukysa.

Explore More ›

Is Tukysa a specialty drug? ›

TUKYSA (tucatinib) prescriptions are filled through specialty pharmacies in the TUKYSA network or through dispensing physician practices and hospital pharmacies that can purchase the product through their specialty distributors.

Learn More Now ›

What is the success rate of panitumumab? ›

Response rates with panitumumab vs bevacizumab were 80.2% vs 68.6%, respectively, for left-sided tumors (difference, 11.2%; 95% CI, 4.4%-17.9%) and 74.9% vs 67.3% overall (difference, 7.7%; 95% CI, 1.5%-13.8%).

Explore More ›

What is the success rate of Verzenio? ›

Overall survival was 46.7 months in women taking the Verzenio combination compared with 37.3 months in those taking the placebo combination. 48.1% of women responded to the Verzenio combination compared with 21% of women taking the placebo combination.

Show Me More ›

What is the success rate of Perjeta? ›

Research table: Pertuzumab (Perjeta) for metastatic breast cancer treatment

Study	Study Population (number of participants)	Overall Survival at One Year
CLEOPATRA study [4-7]	808	94% (92-97%)*
		89% (86-92%)*
PHEREXA study [8]	452	90%†
		85%†

1 more row

View Details ›

What is the success rate of Ibrance? ›

Excluding those dropouts, Ibrance showed a slightly better number, slashing the risk of death by 13.1%. In patients who enjoyed longer than a year of disease-free status, Ibrance cut the risk of death by 27.2%.