Ramucirumab
Intravenous infusion | |
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ATC code | |
Legal status | |
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Pharmacokinetic data | |
Metabolism | Probably proteases |
Elimination half-life | 14 days |
Identifiers | |
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UNII | |
Chemical and physical data | |
Formula | C6374H9864N1692O1996S46 |
Molar mass | 143609.63 g·mol−1 |
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Ramucirumab
Approved uses
In April 2014, the US
Ramucirumab has also been studied in combination with paclitaxel (a type of chemotherapy) and received additional FDA approval on 5 November 2014 as a treatment for people with advanced gastric cancer or GEJ adenocarcinoma after prior treatment with fluoropyrimidine- or platinum-based chemotherapy. The approval was based on the results of the RAINBOW trial, that compared ramucirumab plus paclitaxel or paclitaxel alone.[8]
In December 2014, the FDA approved ramucirumab in combination with
In April 2015, ramucirumab was approved by FDA for the treatment of patients with metastatic
In May 2019, ramucirumab was approved by FDA as a single agent treatment for
Contraindications
Under the European approval, NSCLC therapy with ramucirumab is contraindicated when there is tumour
Side effects
The most common adverse effects in a study investigating ramucirumab monotherapy were
Interactions
In studies, no interactions were observed with paclitaxel, docetaxel, or irinotecan.[12][14]
Pharmacology
Mechanism of action
Ramucirumab is a direct
Clinical trials
In September 2013, the manufacturer Eli Lilly announced that its Phase III study for ramucirumab failed to hit its primary endpoint on progression-free survival among women with metastatic breast cancer.[16][17]
In June 2014, a phase III trial of the drug reported it failed to improve
In February 2016, it was reported that a phase II trial of adding ramucirumab to docetaxel improved progression-free survival (PFS) compared with docetaxel alone in locally advanced or metastatic
Between 2016 and 2018, 26 hospitals in Italy conducted a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial to evaluate the safety and effectiveness of the anti-VEGFR-2 antibody ramucirumab combined with gemcitabine in patients with pretreated pleural mesothelioma. Combining ramucirumab to standard second line gemcitabine significantly improved overall survival after failure of first-line chemotherapy, with a favourable safety profile.[21]
References
- ^ "Prescription medicines: registration of new chemical entities in Australia, 2015". Therapeutic Goods Administration (TGA). 21 June 2022. Retrieved 10 April 2023.
- ^ "Health Canada New Drug Authorizations: 2015 Highlights". Health Canada. 4 May 2016. Retrieved 7 April 2024.
- ^ Statement On A Nonproprietary Name Adopted By The USAN Council - Ramucirumab, American Medical Association.
- ^ "FDA OKs Lilly's blockbuster hopeful ramucirumab for stomach cancer". FierceBiotech. 21 April 2014.
- ^ "Cyramza official website".
- S2CID 41960459.
- PMID 28386297.
- PMID 25240821.
- S2CID 5078660.
- .
- ^ Research, Center for Drug Evaluation and (10 May 2019). "FDA approves ramucirumab for hepatocellular carcinoma". FDA.
- ^ a b "Cyramza: EPAR – Product Information" (PDF). European Medicines Agency. 21 January 2015.
- ^ Haberfeld, H, ed. (2017). Austria-Codex (in German). Vienna: Österreichischer Apothekerverlag. Cyramza 10 mg/ml Konzentrat zur Herstellung einer Infusionslösung.
- ^ a b FDA Professional Drug Information on Cyramza.
- ^ Ramucirumab (Cyramza) package insert
- ^ Clinical trial number NCT00703326 for "Phase III Study of Docetaxel + Ramucirumab or Placebo in Breast Cancer" at ClinicalTrials.gov
- ^ Carroll J (26 September 2013). "In another stinging setback, Eli Lilly's ramucirumab fails PhIII breast cancer study". Retrieved 27 September 2013.
- ^ Philippidis A. "Lilly's Cyramza Fails Phase III Trial in Liver Cancer". Genetic Engineering & Biotechnology News. Archived from the original on 9 April 2016. Retrieved 12 June 2014.
- ^ Levitan D (February 2016). "Added to Docetaxel Extends PFS in Urothelial Carcinoma". Cancer Network. Archived from the original on 2 March 2020. Retrieved 4 March 2016.
- ^ Clinical trial number NCT02426125 for "A Study of Ramucirumab (LY3009806) Plus Docetaxel in Participants With Urothelial Cancer (RANGE)" at ClinicalTrials.gov
- S2CID 237471286.