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Safety in Lactation: Other antineoplastic drugs

23 September 2020Antineoplastic agents, whether used as monotherapy or in combination with other antineoplastics, are contra-indicated in breastfeeding (unless indicated below) because of their effects on dividing…
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Refrigerated Storage

HerceptinRoche Products Ltd

Roche Products Ltd
Herceptin
600mg solution for injection in vial

In the event of an inadvertent temperature excursion the following data may be used:
Once removed from the refrigerator Herceptin subcutaneous formulation must be administered within 6 hours and should not be kept above 30°C.
Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

28 September 2020
London MI Service

Herceptin Roche Products Ltd

Roche Products Ltd
Herceptin
150mg 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

Herzuma Napp Pharmaceuticals

Napp Pharmaceuticals
Herzuma
Powder for concentrate for solution for infusion, 150mg and 420mg

In the event of an inadvertent temperature excursion the following data may be used:
In-house stability data shows Herzuma 150mg was stable for 36 months and Herzuma 420mg was stable for 12 months at storage conditions (2°C to 8°C) when exposed to stress/cycling stability conditions (a total of 12 days at temperatures cycling between -20 ± 5°C and 40 ± 2°C).

In-house stability data from the manufacturers have shown that the unopened vials may be kept up to 25°C for 6 months, or up to 40°C for 3 months.

Please also refer to the manufacturer’s product literature for recommended storage information at https://www.medicines.org.uk

28 January 2022
London MI Service

Lactation Safety Information

No
No published evidence of safety
Serious adverse effects reported in adults
Low levels anticipated in milk due to the drug’s properties and likely to be degraded in infant’s GI tract. However, the effects on the infant of even small amounts in breast milk are unknown
16 September 2020

New Medicines

ZercepacHER2-positive early stage and metastatic breast cancer and metastatic HER2 positive gastroesophageal cancer

Information

Zercepac
Biosimilar
Accord Healthcare
Henlius

Development and Regulatory status

Launched
Launched
Phase III Clinical Trials
September 2020
Sep 21MHRA grants a licence for Zercepac 60mg and 420mg powder for concentrate for solution for infusion. This is in addition to 150mg strength already launched [8].
Sep 20Launched in the UK [7].
Aug 20Zercepac licensed (EPAR on EMEA website) [6].
May 20Recommended for EU approval by CHMP - the full indications include metastatic and early breast cancer and metastatic gastric cancer as for the originator product [5].
Jun 19Henlius announces that the EMA has accepted for review the MAA for trastuzumab biosimilar HLX02 [1].

Category

Anti-HER2 monoclonal antibody
In 2012, the estimated age-adjusted annual incidence of breast cancer in 40 European countries was 94.2/100,000 and the mortality 23.1/100,000 [2]
HER2-positive early stage and metastatic breast cancer and metastatic HER2 positive gastroesophageal cancer
Intravenous infusion

Trial or other data

Nov 19HLX02 achieved similar overall response rate to reference trastuzumab in women with HER2+ recurrent or previously untreated metastatic breast cancer, according to a large, randomised phase III study to be reported at the ESMO Asia Congress 2019 [4].
Jun 19PIII trial NCT03084237 comparing HLX02 with Herceptin ongoing, recruiting completed [3].

Evidence based evaluations

trastuzumab biosimilar (EG12014)HER2-positive breast cancer

Information

trastuzumab biosimilar (EG12014)
Biosimilar
Sandoz
Sandoz

Development and Regulatory status

Phase III Clinical Trials
Phase III Clinical Trials
Pre-registration (Filed)
Dec 21Sandoz announces submission of its Biologics License Application (BLA) for a proposed biosimilar trastuzumab [5]
Jun 19Sandoz announced on 30 April 2019 that it had signed an agreement with Taiwan’s EirGenix to market a proposed trastuzumab biosimilar [1].

Category

Anti-HER2 monoclonal antibody
In 2012, the estimated age-adjusted annual incidence of breast cancer in 40 European countries was 94.2/100,000 and the mortality 23.1/100,000 [2]
HER2-positive breast cancer
Intravenous infusion

Trial or other data

Mar 21PIII trial NCT03433313 of EG12014 has met its primary endpoint, EG12014 has shown equivalent efficacy to Herceptin® in regards to its clinical response (pathologic complete response, pCR), in addition to demonstrating a comparable safety profile [4].
Jun 19PIII trial comparing EG12014 with Herceptin (NCT03433313), primary completion date Aug 2020 [3].