Panitumumab

Grey

Brand Name(s):Vectibix

Indication:Metastatic colon cancer as monotherapy after failure of fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy regimens

Rationale:1

Considered:Nov-08

Review Date:Oct-20

Comments:
MHRA DSU Sept 2013
Summary

In the treatment of metastatic colorectal cancer, evidence of wildtype RAS status (at exons 2, 3, and 4 of KRAS and NRAS) is required before initiating treatment with panitumumab alone or in combination with other chemotherapy. Inferior progression-free survival and overall survival have been shown in patients with RAS mutations beyond KRAS exon 2 who received panitumumab combined with FOLFOX (oxaliplatin-containing) chemotherapy versus FOLFOX alone.
Further info at:http://www.mhra.gov.uk/Safetyinformation/DrugSafetyUpdate/CON314896
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NICE technology appraisal guidance 242
Cetuximab, bevacizumab and panitumumab for the treatment of metastatic colorectal cancer after first-line chemotherapy

Panitumumab monotherapy is not recommended for the treatment of people with metastatic colorectal cancer that has progressed after first-line chemotherapy.

People currently receiving cetuximab monotherapy or combination chemotherapy, bevacizumab in combination with non-oxaliplatin chemotherapy, or panitumumab monotherapy for the treatment of metastatic colorectal cancer that has progressed after first-line chemotherapy should have the option to continue treatment until they and their clinician consider it appropriate to stop.
Issued: January 2012
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Direct Healthcare Professional Communication on the importance of establishing KRAS status prior to treatment with Vectibix.
Dear Healthcare Professional
Summary
* The combination of Vectibix with oxaliplatin-containing chemotherapy is contraindicated for patients with mutant KRAS mCRC or for whom KRAS mCRC status is unknown
* Vectibix® has shown no benefit in patients whose tumours carry mutated KRAS.
* A detrimental effect on progression free survival and overall survival has been demonstrated in patients with mutant KRAS status receiving Vectibix with FOLFOX chemotherapy.
* Evidence of wild-type KRAS status is required prior to initiating treatment with Vectibix.
15 November 2011

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Panitumumab is contraindicated in patients with a history of severe or life-threatening hypersensitivity reactions to this medicine
* Serious infusion-related reactions are unpredictable and can occur suddenly. Panitumumab should be permanently discontinued if a severe or life-threatening reaction occurs
* In patients with a mild or moderate infusion-related reaction, the infusion rate should be reduced for the duration of the infusion; it is recommended to maintain this lower infusion rate in all subsequent infusions
* Hypersensitivity reactions occurring more than 24 hours after infusion have also been reported. Patients should be warned of a possible late-onset reaction and instructed to contact their physician if symptoms of hypersensitivity occur.

MHRA Drug Safety Update Volume 3 Issue 10 May 2010