dm+d

24002411000001100

Articles

In use product safety assessment report for trastuzumab

3 May 2019A UKMi Product Safety assessment on  trastuzumab products (including the biosimilars) which describes the in-use medication safety considerations resultant from the product’s presentation or other…

Trastuzumab

12 January 2016Antibody-drug conjugate, consists of DM1 cancer-cell killing agent linked to HER2-targeted antibody, trastuzumab
Search Articles

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.

Storage at ambient temperature: not provided by the manufacturer.

 

28 September 2020
London MI Service

New Medicines

KadcylaHER2-positive early breast cancer - adjuvant monotherapy

Information

Kadcyla
Licence extension / variation
Roche
Roche

Development and Regulatory status

Launched
Launched
Launched
Dec 19Approved in EU [18]
Nov 19Recommended for EU approval by CHMP - the additional indication is "as a single agent, ... for the adjuvant treatment of adult patients with HER2-positive early breast cancer who have residual invasive disease, in the breast and/or lymph nodes, after neoadjuvant taxane-based and HER2-targeted therapy" [17].
May 19Approved in US [15].
Feb 19Filed in EU [16].
Feb 19Filed in the US, where it has breakthrough therapy designation, and will be reviewed under the FDA´s Real-Time Oncology Review and Assessment Aid pilot programmes, which aim to explore a more efficient review process to ensure safe and effective treatments are available to patients as early as possible [12,13].
Feb 19Q1 EU filing using KATHERINE data expected to follow in 2019 [14].
Apr 18Filings for use with or without Perjeta now planned for 2020 [9].
Oct 16EU & US filings will not be until at least 2019 [8].
Jul 14EU & US filings now planned for 2017 or beyond [6].
Feb 14Expected filing from 2016 [4].
Jan 13PIII study starts Mar 13 [1].

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.
HER2-positive early breast cancer - adjuvant monotherapy
Intravenous

Further information

Yes
June 2020

Trial or other data

Dec 18PIII KATHERINE study (n=1486) is published. The study found that risk of recurrence of invasive breast cancer or death was 50% lower with adjuvant trastuzumab emtansine than with trastuzumab (HR 0.50; 95% CI, 0.39-0.64; p<0.001); 88.3 vs. 77.0%.free of invasive disease at 3 years) [11].
Oct 18Roche announced the PIII KATHERINE study met its primary endpoint, showing trastuzumab emtansine (Kadcyla) as a single agent significantly reduced the risk of disease recurrence or death (invasive disease-free survival, iDFS) vs trastuzumab (Herceptin) as an adjuvant treatment in people with HER2-positive early breast cancer who have residual tumour present in the breast or axillary lymph nodes following preoperative therapy. The safety profile of Kadcyla in the KATHERINE study was consistent with previous clinical trials and no new safety signals were identified. Full results will be submitted to health authorities around the world, and will be presented at the 2018 San Antonio Breast Cancer Symposium in December [10].
Oct 16Data expected in 2018 from KATHERINE, and 2019 from KAITLIN [8].
Jun 15Enrolment complete in PIII KAITLIN study (n=1,850) in operable HER2-positive early BC, comparing Kadcyla + pertuzumab + chemo with Herceptin + pertuzumab + chemo [7].
Oct 13NCT01966471 This two-arm, randomized, open-label, multicenter PIII study will evaluate trastuzumab emtansine + pertuzumab vs trastuzumab + pertuzumab + a taxane as adjuvant therapy in 2500 patients with HER2-positive primary invasive breast cancer who have undergone surgery and anthracycline-based chemotherapy. The primary outcome is invasive disease-free survival. Anticipated time on HER2 targeted study treatment is up to 1 year. The study starts Feb 14 and is due to complete Jan 24 (primary data collection 2018) [3].
Apr 13First pt enrolled in PIII KATHERINE (NCT01772472) trial [2].
Jan 13NCT01772472 is a PIII , randomized, open-label study evaluating trastuzumab emtansine vs trastuzumab as adjuvant therapy in 1484 patients with HER2-positive breast cancer who have residual tumour present in the breast or axillary lymph nodes following preoperative therapy. Eligible patients will receive either trastuzumab emtansine 3.6mg/kg or trastuzumab 6mg/kg IV every 3 weeks for 14 cycles. Radiotherapy and/or hormone therapy will be given if indicated. The primary endpoint is Invasive disease-free survival. The study starts Mar 13 and is due to complete Aug 23 [1].

Evidence based evaluations

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
Suspended

Evidence based evaluations