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Refrigerated Storage

KadcylaRoche Products Ltd

Roche Products Ltd
Kadcyla
100 mg and 160 mg Powder for concentrate for solution for infusion

Contact Roche Products Ltd in all cases where a deviation from the recommended storage conditions has occurred. Refer to the current BNF for company contact details.

28 September 2020
London MI Service

New Medicines

KadcylaMetastatic HER2-positive, PD-L1-positive breast cancer - second-line plus with atezolizumab

Information

Kadcyla
Licence extension / variation
Roche
Roche

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Antibody-drug conjugate, consists of DM1 cancer-cell killing agent linked to HER2-targeted antibody, trastuzumab
In 2012, the estimated age-adjusted annual incidence of breast cancer in 40 European countries was 94.2 per 100,000 and the mortality 23.1 per 100,000. About 15% of breast cancers have amplification of the HER2 gene and these cancers have an intrinsically worse prognosis than other cancers [1]. Breast cancer is highly heterogeneous, and PD-1/PD-L1 expression may vary among different molecular subtypes [2].
Metastatic HER2-positive, PD-L1-positive breast cancer - second-line plus with atezolizumab
Intravenous infusion

KadcylaOperable HER2-positive early breast cancer - in combination with pertuzumab

Information

Kadcyla
Licence extension / variation
Roche
Roche

Development and Regulatory status

Discontinued
Discontinued
Discontinued
Jul 20No longer in development and Roche has no plans to file [4].

Category

Antibody-drug conjugate, consists of DM1 cancer-cell killing agent linked to HER2-targeted antibody, trastuzumab
In 2010, there were 41,612 new cases of BC in England. Around 90-95% of pts present with localised (stage I-III) disease & are eligible for surgery & adjuvant treatment. Amplification of the HER2 gene & over-expression of the receptor occurs in 15-20% of BCs & is associated with a worse prognosis than HER2-negative tumours of similar stage and grade. Adding adjuvant trastuzumab for 12 months to standard chemotherapy is the standard of care, but many women develop recurrent disease [1].
Operable HER2-positive early breast cancer - in combination with pertuzumab
Intravenous

Further information

Yes

Evidence based evaluations