- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
Lumykras is a cancer medicine used to treat adults with non-small cell lung cancer (NSCLC) when the cancer is advanced, and its cells have a particular genetic change. The change is in the gene KRAS and is known as ‘KRAS G12C’. Lumykras is given when the disease has progressed after receiving systemic treatment (treatment affecting the whole body).
Lumykras contains the active substance sotorasib.
The medicine can only be obtained with a prescription, and treatment with Lumykras should be started by a doctor who is experienced in using cancer medicines.
The patient’s cancer should be tested before starting treatment to confirm it has the genetic change affecting KRAS (KRAS G12C).
Lumykras is available as tablets and is taken by mouth. The recommended dose is 960 mg once per day. Treatment is continued until the disease gets worse or side effects become too severe.
If certain side effects develop, the doctor may decide to reduce the dose to 480 mg once per day and then, if needed, to 240 mg once per day. Treatment should be stopped if side effects are too great at the lowest dose (240 mg).
For more information about using Lumykras, see the package leaflet or contact your doctor or pharmacist.
Genetic changes to the KRAS gene can produce an altered protein that causes the uncontrolled growth of cancer cells. The active substance in Lumykras, sotorasib, attaches to this altered protein inside cancer cells. This blocks the protein from acting, interrupting the chemical messages the cancer cells need for growing and spreading, and it also encourages processes that cause the cancer cells to die.
In one main study involving 124 patients, Lumykras was effective in treating adults with NSCLC with the KRAS G12C genetic change whose disease had progressed after previously being treated with other cancer medicines. Lumykras was not compared with any other treatment or placebo (a dummy treatment).
Response to treatment (shrinkage in the size of the cancer) was assessed using body scans. Around 37% (46 out of 124) of the patients showed partial or complete cancer shrinkage after treatment with Lumykras. On average, responses lasted for just over 11 months.
The most common side effects with Lumykras (which may affect more than 1 in 5 people) are diarrhoea, nausea (feeling sick) and tiredness. The most common severe side effects with Lumykras (which may affect up to 1 in 100 people) are increased levels of certain liver enzymes (a sign of possible liver problems) and liver injury. For the full list of side effects and restrictions of Lumykras, see the package leaflet.
There are currently few treatment options for patients with advanced NSCLC with KRAS G12C mutations for whom the cancer has progressed after systemic treatment with cancer medicines, and current treatments have limited effectiveness. Although the main study did not compare Lumykras with another cancer treatment, it showed that the medicine was effective at treating the cancer including in patients whose cancer had progressed after several different treatments. In general, Lumykras’ side effects were considered manageable.
The European Medicines Agency, therefore, decided that Lumykras’ benefits are greater than its risks and it can be authorised for use in the EU.
Lumykras has been given ‘conditional authorisation’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the European Medicines Agency will review any new information that becomes available and this overview will be updated as necessary.
Since Lumykras has been given conditional authorisation, the company that markets Lumykras will provide further information from an ongoing study. The study will compare the efficacy and safety of Lumykras in treating previously treated NSCLC with KRAS G12C mutation with those of another cancer medicine, docetaxel.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Lumykras have been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Lumykras are continuously monitored. Suspected side effects reported with Lumykras are carefully evaluated and any necessary action taken to protect patients.
Lumykras received a conditional marketing authorisation valid throughout the EU on 06 January 2022.
Lumykras : EPAR - Medicine Overview
Reference Number: EMA/685702/2021
English (EN) (136.1 KB - PDF)
First published:
български (BG) (164.27 KB - PDF)
First published: 31/03/2022
español (ES) (132.2 KB - PDF)
First published: 31/03/2022
čeština (CS) (155.61 KB - PDF)
First published: 31/03/2022
dansk (DA) (132.71 KB - PDF)
First published: 31/03/2022
Deutsch (DE) (136.13 KB - PDF)
First published: 31/03/2022
eesti keel (ET) (127.13 KB - PDF)
First published: 31/03/2022
ελληνικά (EL) (163.96 KB - PDF)
First published: 31/03/2022
français (FR) (133.65 KB - PDF)
First published: 31/03/2022
hrvatski (HR) (154.12 KB - PDF)
First published: 31/03/2022
italiano (IT) (131.69 KB - PDF)
First published: 31/03/2022
latviešu valoda (LV) (160.1 KB - PDF)
First published: 31/03/2022
lietuvių kalba (LT) (152.4 KB - PDF)
First published: 31/03/2022
magyar (HU) (154.13 KB - PDF)
First published: 31/03/2022
Malti (MT) (155.94 KB - PDF)
First published: 31/03/2022
Nederlands (NL) (133.53 KB - PDF)
First published: 31/03/2022
polski (PL) (156.97 KB - PDF)
First published: 31/03/2022
português (PT) (133.16 KB - PDF)
First published: 31/03/2022
română (RO) (143.97 KB - PDF)
First published: 31/03/2022
slovenčina (SK) (154.19 KB - PDF)
First published: 31/03/2022
slovenščina (SL) (153.71 KB - PDF)
First published: 31/03/2022
Suomi (FI) (129.23 KB - PDF)
First published: 31/03/2022
svenska (SV) (130.92 KB - PDF)
First published: 31/03/2022
Product information
Lumykras : EPAR - Product Information
English (EN) (340.2 KB - PDF)
First published: Last updated:
български (BG) (490.73 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
español (ES) (322 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
čeština (CS) (401.95 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
dansk (DA) (398.6 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
Deutsch (DE) (428.7 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
eesti keel (ET) (315.07 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
ελληνικά (EL) (412.95 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
français (FR) (474.84 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
hrvatski (HR) (465.29 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
íslenska (IS) (402.94 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
italiano (IT) (418.08 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
latviešu valoda (LV) (470.21 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
lietuvių kalba (LT) (471.58 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
magyar (HU) (473.91 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
Malti (MT) (541.57 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
Nederlands (NL) (414.79 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
norsk (NO) (394.13 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
polski (PL) (479.05 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
português (PT) (396.78 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
română (RO) (469.9 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
slovenčina (SK) (502.71 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
slovenščina (SL) (463.36 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
Suomi (FI) (412.87 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
svenska (SV) (406.48 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
Latest procedure affecting product information: X/0009
16/05/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics(annex I);
- manufacturing authorisationholder responsible for batch release (annex IIA);
- conditions of themarketing authorisation(annex IIB);
- labelling(annex IIIA);
- package leaflet(annex IIIB).
Lumykras : EPAR - All authorised presentations
English (EN) (79.51 KB - PDF)
First published: Last updated:
български (BG) (58.38 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
español (ES) (50.18 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
čeština (CS) (53.22 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
dansk (DA) (52.23 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
Deutsch (DE) (50.38 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
eesti keel (ET) (48 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
ελληνικά (EL) (55.99 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
français (FR) (51.14 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
hrvatski (HR) (53.95 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
íslenska (IS) (51.81 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
italiano (IT) (50.18 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
latviešu valoda (LV) (54.45 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
lietuvių kalba (LT) (53.47 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
magyar (HU) (53.24 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
Malti (MT) (53.92 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
Nederlands (NL) (49.39 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
norsk (NO) (51.56 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
polski (PL) (55.08 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
português (PT) (51.37 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
română (RO) (53.93 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
slovenčina (SK) (56.22 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
slovenščina (SL) (62.82 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
Suomi (FI) (49.85 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
svenska (SV) (50.32 KB - PDF)
First published: 31/03/2022Last updated: 23/05/2024
Product details
- Name of medicine
Lumykras
- Active substance
sotorasib
- International non-proprietary name (INN) or common name
sotorasib
- Therapeutic area (MeSH)
Carcinoma, Non-Small-Cell Lung
- Anatomical therapeutic chemical (ATC) code
L01XX73
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.
Authorisation details
- EMA product number
EMEA/H/C/005522
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.
Conditional approval
This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.
- Marketing authorisation holder
Amgen Europe BV
Minervum 7061
4817ZK Breda
The Netherlands- Opinion adopted
11/11/2021
- Marketing authorisation issued
06/01/2022
- Revision
5
Assessment history
Lumykras : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (152.66 KB - PDF)
First published: Last updated:
Lumykras : EPAR - Public Assessment Report
AdoptedReference Number: EMA/706135/2021
English (EN) (5.32 MB - PDF)
First published:
CHMP summary of opinion for Lumykras
AdoptedReference Number: EMA/624008/2021
English (EN) (100.47 KB - PDF)
First published:
News on Lumykras
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 8-11 November 2021
More information on Lumykras
- EMEA-002690-PIP02-22 - paediatric investigation plan
This page was last updated on
