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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

Enhertu Daiichi Sankyo UK Ltd

Daiichi Sankyo UK Ltd
Enhertu
100mg powder for concentrate for solution for infusion

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

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

12 November 2021
London MI Service

New Medicines

EnhertuMetastatic breast cancer, unresectable or metastatic, HER2-positive, at least two previous anti-HER2 regimens

Information

Enhertu
New molecular entity
Daiichi Sankyo
Daiichi Sankyo

Development and Regulatory status

Launched
Launched
Launched
March 2021
Mar 21Available in the UK. 100mg powder for conc for soln for inf in vial, 1=£1,455 [19].
Feb 21Approved in the UK [18].
Jan 21Has been available in the US since Jan 20 [17].
Jan 21Granted conditional approval in EU [16].
Dec 20Recommended for EU approval by CHMP - the full indication is "for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti HER2 based regimens." It should be prescribed by physicians experienced in the use of anticancer medicinal products [15].
Jul 20European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for trastuzumab deruxtecan for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens and granted accelerated assessment [13].
Mar 20EU filing based on DESTINY-Breast01 planned for H2 20 [12].
Feb 20Analysts predict this will be one of the top 10 most-anticipated new US drug launches of 2020 based on estimated global sales in 2024 [11].
Dec 19Filings based on data from DESTINY-Breast 02 expected in 2021 [10].
Dec 19Approved in US via accelerated approval process, based on tumour response rate; continued licensing may be conditional on confirmation of clinical benefit [9].
Oct 19Filed in US with priority review [7].
Sep 19Filings based on DESTINY-Breast 01 planned for H2 2019 [6].
Jun 19Filings planned for 2020+ [5].
Aug 17US FDA grants Breakthrough Therapy Designation to trastuzumab deruxtecan for treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1) [3].
Dec 16US FDA grants Fast Track designation to trastuzumab deruxtecan for treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including ado-trastuzumab emtansine [3].

Category

Antibody-drug conjugate composed of an anti-HER2 antibody, trastuzumab, and a DNA topoisomerase I inhibitor, a DX 8951 derivative. The HER2 antibody is attached to the topoisomerase I inhibitor by a tetrapeptide linker.
In 2014, there were approximately 46,500 new diagnoses of breast cancer in England. It is estimated that approximately 15-25% of women with breast cancer will have HER2-positive tumours [1].
Metastatic breast cancer, unresectable or metastatic, HER2-positive, at least two previous anti-HER2 regimens
Intravenous infusion

Further information

Yes

Trial or other data

Dec 19Results from the PII, single arm DESTINY-Breast01 trial found that trastuzumab deruxtecan led to an objective response rate of 60.9%. A cure rate of 6% was seen, and disease control rate of 97% (including some patients who experienced some tumour shrinkage, but not sufficient to be considered responders). Patients had received an average of six prior treatments. Side effects were experienced by 99% of patients, which included nausea, vomiting and low white blood cell counts. 15% of patients stopped treatment due to adverse events. Interstitial lung disease was experienced by 25 patients, four of whom died from the disease [8].
May 19AstraZeneca and Daiichi Sankyo announce PII DESTINY-Breast01 trial meets primary endpoint of objective response rate. Submission of a NDA to US FDA is planned for the second half of this year [4].
Aug 18PIII DESTINY-Breast03 trial to compare the anti-tumour activity as well as the safety and efficacy of trastuzumab deruxtecan versus T-DM1 (trastuzumab emtansine) in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane (DS8201A-U302; NCT03529110). Progression-free survival is the primary endpoint of the trial. 500 patients will be recruited in the US and Japan. Collection of primary outcome data should complete Feb 22 [2].

Evidence based evaluations

EnhertuHER2-positive gastric or gastroesophageal cancer - after previous trastuzumab therapy

Information

Enhertu
Licence extension / variation
Daiichi Sankyo
Daiichi Sankyo

Development and Regulatory status

None
Pre-registration (Filed)
Launched
Yes
Nov 21EMA starts review of an application for a licence extension to include monotherapy treatment of adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior anti-HER2-based regimen for Enhertu based on final results from studies DS8201 A J202 (DESTINY Gastric01) and DS8201-A-U205 (DESTINY Gastric02) [13].
Jan 21Approved by US FDA for the treatment of adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Approval was based on data from the PII DESTINT-Gastric01 study. [12]
Oct 20The sBLA is based on results from the PII DESTINY-Gastric01 trial [11].
Oct 20FDA accepts sBLA with priority review. A regulatory decision is expected Q1 21 [9].
Oct 20Approved and launched in Japan [7].
Sep 20Has been filed in Japan [6].
May 20Enhertu granted Breakthrough Therapy designation and orphan status in the US for treatment of gastric cancer, including gastro-esophageal junction cancer [7]

Category

Antibody-drug conjugate composed of an anti-HER2 antibody, trastuzumab, and a DNA topoisomerase I inhibitor, a DX 8951 derivative. The HER2 antibody is attached to the topoisomerase I inhibitor by a tetrapeptide linker.
Gastric cancer is the second most common cause of cancer-related death in the world. It is a difficult disease to cure, mainly because most patients present with advanced disease. Around 6,700 people are diagnosed with stomach cancer in the UK each year [2014-16 data]. Around 20% of gastric cancers are HER2 positive. The number of people in the UK diagnosed with stomach cancer has been falling over the last 10 years. [1-3].
HER2-positive gastric or gastroesophageal cancer - after previous trastuzumab therapy
Intravenous infusion

Further information

Yes

Trial or other data

Sep 21Efficacy and safety data from the DESTINY-Gastric02 trial (NCT04014075; DS8201-A-U205) released by Daiichi Sankyo. The single-arm trial started in Jul 19 and included patients with HER2-positive, unresectable or metastatic gastric or gastro-oesophageal junction adenocarcinoma who have progressed on or after a trastuzumab-therapy. It enrolled 79 patients in the US, Belgium, Italy, Spain and the UK. Trastuzumab deruxtecan (6.4 mg/kg) demonstrated a confirmed overall response rate (ORR) of 38.0% (n=30; CI: 27.3-49.6) as assessed by independent central review (ICR). Out of a total of 79 patients treated with trastuzumab deruxtecan, three (3.8%) complete responses (CR) and 27 (34.2%) partial responses (PR) were observed. These results were consistent with those from the PII DESTINY-Gastric01 trial [14].
Jan 21In the PII DESTINY-Gastric01 study, Enhertu-treated pts had 41% reduction in the risk of death vs. chemotherapy-treated pts. At a pre-specified interim analysis, pts treated with Enhertu demonstrated a median OS of 12.5 months vs. 8.4 months with chemotherapy, a confirmed ORR of 40.5% with Enhertu vs. 11.3% with chemotherapy. The complete response rate (CRR) was 7.9% with Enhertu and partial response rate (PRR) was a 32.5% (vs. 0% and 11.3% for pts treated with chemotherapy). [12]
Dec 20PII DESTINY-Gastric-1 trial is due to finish following up patients. It completed collection of primary outcome data in Nov 19 [10].
May 20Detailed results from PII Gastric-01 trial presented at the American Society of Clinical Oncology virtual event. Patients treated with trastuzumab deruxtecan had a 41% reduction in the risk of death vs patients treated with chemotherapy (HR 0.59; 95% CI 0.39-0.88; p=0.0097) at a pre-specified interim analysis. The median OS was 12.5 months vs 8.4 months with chemotherapy. The estimated OS rate at one year in the trastuzumab deruxtecan arm was 52.1% and 28.9% with the chemotherapy arm [8].
Apr 20DESTINY-Gastric-1 trial meets primary endpoint [5].
Jan 20The PII open label, multi-centre, DESTINY-Gastric-1 trial of trastuzumab deruxtecan met its primary endpoint of % of pts with best objective Response within 22 months. It assessed the safety and efficacy of trastuzumab deruxtecan in 189 pts from Japan and South Korea with HER2+ advanced gastric cancer or gastroesophageal junction adenocarcinoma (defined as IHC3+ or IHC2+/ISH+) who had progressed on >2 prior treatements including 5-FU, platinum chemotherapy and trastuzumab. Pts were randomised 2:1 to receive trastuzumab deruxtecan (6.4mg/kg once every 3 weeks) or either paclitaxel or irinotecan at standard doses. Secondary endpoints include OS, progression-free survival, duration of response, disease control rate and time to treatment failure as well as pharmacokinetic and safety endpoints. The estimated primary completion date is Sept 2020. [3,4]

Evidence based evaluations

EnhertuUnresectable or metastatic, HER2-positive breast cancer - second-line

Information

Enhertu
Licence extension / variation
Daiichi Sankyo
Daiichi Sankyo

Development and Regulatory status

Phase III Clinical Trials
Recommended for approval (Positive opinion)
Launched
Jun 22CHMP recommends a change to the indications for Enhertu to permit use second-line (previously only licensed after two or more prior anti HER2 based regimens). The proposed revised indication is "for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti HER2 based regimens" [11].
May 22FDA approves Enhertu for use in patients with unresectable or metastatic HER2-positive breast cancer after one prior anti-HER2 therapy, either in the metastatic phase or in the early-stage setting [10].
Jan 22Filing accepted by US FDA for priority review with a regulatory decision expected Q2 22; a Type II Variation application is currently under review by the EMA for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received one or more prior anti-HER2-based regimens. Both submissions are based on results from the DESTINY-Breast03 trial [8].
Oct 21FDA grants Enhertu Breakthrough Therapy designation for adult pts with unresectable or metastatic HER2-positive breast cancer as second line treatment based on PIII DESTINY-Breast03 trial [7]
Sep 20Filings planned for H2 21 [3].

Category

Antibody-drug conjugate composed of an anti-HER2 antibody, trastuzumab, and a DNA topoisomerase I inhibitor, a DX 8951 derivative. The HER2 antibody is attached to the topoisomerase I inhibitor by a tetrapeptide linker.
In 2014, there were approximately 46,500 new diagnoses of breast cancer in England. It is estimated that approximately 15-25% of women with breast cancer will have HER2-positive tumours [1].
Unresectable or metastatic, HER2-positive breast cancer - second-line
Intravenous infusion

Further information

Yes

Trial or other data

Mar 22 PIII DESTINY-Breast03 RCT (NCT03529110; n=524 HER2+ve metastatic, previously on trastuzumab [TZ] & taxane) found significantly more patients on TZ-deruxtecan were alive without disease progression at 1-year vs. TZ-emtansine (75.8 vs. 34.1%; HR 0.28; 95% CI, 0.22-0.37;p<0.001). TZD was linked to ILD and pneumonitis [9].
Sep 21Enhertu was reported to reduce disease progression or death by 71.6% vs. trastuzumab emtansine (Kadcyla) at a ESMO 2021 virtual meeting. Median time to disease progression or death was not reached for Enhertu and was 6.8 months for Kadcyla a blinded independent review. By investigator’s analysis, the median time to progression or death was 25.1 months for Enhertu versus 7.2 months for Kadcyla [6].
Aug 21A planned interim analysis of DESTINY-Breast 03 by the Independent Data Monitoring Committee (IDMC) shows primary endpoint of PFS is achieved [5].
Dec 20PIII DESTINY-Breast03 trial has finished recruiting [4].
Mar 20PIII DESTINY-Breast03 trial is recruiting and in further countries including the EU & UK; collection of primary outcome data still due to complete Feb 22 [2].
PIII DESTINY-Breast03 trial to compare the anti-tumour activity as well as the safety and efficacy of trastuzumab deruxtecan versus T-DM1 (trastuzumab emtansine) in HER2-positive, unresectable and/or metastatic breast cancer subjects previously treated with trastuzumab and taxane (DS8201A-U302; NCT03529110). Progression-free survival is the primary endpoint of the trial. 500 patients will be recruited in the US and Japan. Collection of primary outcome data should complete Feb 22 [2].

Evidence based evaluations

EnhertuUnresectable and/or metastatic non-squamous HER2 positive non-small cell lung cancer (NSCLC) - second-line

Information

Enhertu
Licence extension / variation
Daiichi Sankyo
Daiichi Sankyo

Development and Regulatory status

None
Phase II Clinical Trials
Pre-registration (Filed)
Apr 22US FDA accepts sBLA for priority review [6].
May 20Granted Breakthrough Therapy Designation in the US for the treatment of HER2m metastatic NSCLC [3].

Category

Antibody-drug conjugate composed of an anti-HER2 antibody, trastuzumab, and a DNA topoisomerase I inhibitor, a DX 8951 derivative. The HER2 antibody is attached to the topoisomerase I inhibitor by a tetrapeptide linker.
There are around 47,800 new lung cancer cases in the UK every year, around 130 every day (2015-2017). 25% of patients diagnosed with NSCLC in England in 2013-2014 had curative or palliative chemotherapy, as part of their primary cancer treatment. Mortality rates for lung cancer are projected to fall by 21% in the UK between 2014 and 2035, to 58 deaths per 100,000 people by 2035 [1].
Unresectable and/or metastatic non-squamous HER2 positive non-small cell lung cancer (NSCLC) - second-line
Intravenous infusion

Further information

Yes

Trial or other data

Sep 21Primary results for HER2-mutant pts of DESTINY-Lung01 PII study are published in The New England Journal of Medicine. It showed a confirmed ORR of 54.9% in pts receiving Enhertu. One (1.1%) complete response and 49 (53.8%) partial responses were identified. An actual disease control rate of 92.3% was observed with a tumour size reduction in most pts. After a median follow-up of 13.1 months, the median DoR for Enhertu was 9.3 months. The median PFS was 8.2 months and the median OS was 17.8 months [4].
May 21PII DESTINY-Lung01 study is no longer recruiting and completes collection of primary outcome data [5].
Sep 20PII DESTINY-Lung01 study is recruiting [2].
May 20Results reported from PII DESTINY-Lung01 trial. The primary endpoint of confirmed objective response rate (ORR), assessed by independent central review, was 61.9% for patients treated with Enhertu monotherapy (6.4mg/kg). Patients achieved a disease control rate (DCR) of 90.5% with an estimated median progression-free survival (PFS) of 14.0 months. Median duration of response (DoR) and overall survival (OS) had not yet been reached at the time of data cut-off. Patients were treated with a median of two prior lines of therapy (1-6) with most receiving platinum-based chemotherapy (90.5%) and anti-PD-1 or PD-L1 treatment (54.8%). Median treatment duration was 7.76 months (0.7-14.3) with a median duration of follow-up of 8.0 months (1.4-14.2). As of data cut-off on 25 November 2019, 45.2% of patients with HER2m metastatic NSCLC remained on treatment with Enhertu. The overall safety and tolerability profile of Enhertu in DESTINY-Lung01 was consistent with that seen in the Phase I lung cancer trial and previously reported Enhertu trials.4 The most common Grade 3 or higher treatment-emergent adverse events were decreased neutrophil count (26.2%) and anaemia (16.7%). There were five cases (11.9%) of confirmed treatment-related interstitial lung disease (ILD) and pneumonitis as determined by an independent adjudication committee. All ILD and pneumonitis cases were Grade 2. One Grade 1 ILD is still undergoing adjudication [3].
May 18PII DESTINY-Lung01 study to evaluate the efficacy of trastuzumab deruxtecan in HER2-overexpressing and/or HER2-mutated advanced NSCLC patients starts (NCT03505710). 170 adults will be recruited in the US, Japan, France, Netherlands and Spain. Primary outcome is overall response rate; collection of these data is due to complete Feb 21 [2].

EnhertuMetastatic HER2-low breast cancer

Information

Enhertu
Licence extension / variation
Daiichi Sankyo
Daiichi Sankyo

Development and Regulatory status

Phase III Clinical Trials
Pre-registration (Filed)
Phase III Clinical Trials
Jun 22EMA validates Type II Variation application for trastuzumab deruxtecan as monotherapy for the treatment of adult patients with unresectable or metastatic HER2 low breast cancer [11]
Apr 22Granted Breakthrough Therapy designation by US FDA [8].
Sep 20Filings now expected 2022 or later [4].
Sep 19Filings based on DESTINY-Breast 04 are planned for 2021 at the earliest [3].

Category

Antibody-drug conjugate composed of an anti-HER2 antibody, trastuzumab, and a DNA topoisomerase I inhibitor, a DX 8951 derivative. The HER2 antibody is attached to the topoisomerase I inhibitor by a tetrapeptide linker.
In 2014, there were approximately 46,500 new diagnoses of breast cancer in England. It is estimated that approximately 15-25% of women with breast cancer will have HER2-positive tumours [1].
Metastatic HER2-low breast cancer
Intravenous infusion

Further information

Yes

Trial or other data

Jun 22Results of PIII DESTINY-Breat04 RCT reported in NEJM [10].
Jun 22Enhertu showed consistent results across all subgroups tested in PIII DESTINY-Breat04 study. In patients with HR-positive disease, which constitutes the primary endpoint analysis, Enhertu cut the risk of disease progression or death by 49%. The drug nearly doubled the median progression-free survival (PFS) to 10.1 months, versus 5.4 months for chemo. Among those with HR-negative disease, the size of the risk reduction on progression-free survival was similar at 54%. The median PFS between Enhertu and chemo were 8.5 months and 2.9 months, respectively. Within the HR-positive group, in patients who had received prior treatment with a CDK4/6 inhibitor, the progression-free risk reduction was 45%. For about a quarter of the trial population who had no prior CDK4/6 experience, that number was 58%. Enhertu showed similar results in IHC 1+ and IHC 2+ subgroups, cutting the PFS risk by 52% and 45%, respectively, among HR-positive patients [9].
Jun 22Data released from PIII DESTINY-Breat04 study. Enhertu reduced the risk of disease progression or death by a 50% and the risk of death by 36% in patients with previously treated HER2-low metastatic breast cancer. At a median follow-up of 18.4 months, Enhertu extended the median time patients had lived without disease worsening to 9.9 months, versus 5.1 months for patients who got physician choice of chemotherapy. The drug prolonged patients ’ lives to a median of 23.4 months, compared with 16.8 months for chemo. The Destiny-Breast04 readout is described as a “pivotal moment” because for the first time, a HER2-directed therapy has identified the patient population of HER2-low, including disease that is hormone receptor-positive and -negative, which covers about half of all breast cancer patients, and has shown impressive efficacy [9].
Feb 22AstraZeneca report positive high-level results from pivotal DESTINY-Breast04 PIII trial showed Enhertu demonstrated a statistically significant and clinically meaningful improvement in both progression-free survival and overall survival in patients with HER2-low unresectable and/or metastatic breast cancer regardless of hormone receptor status versus physician´s choice of chemotherapy. AstatZeneca state that the improvements covered patients regardless of their HR status and were statistically significant and meaningful. Detailed results will be presented at an upcoming medical meeting and shared with regulatory authorities [7].
Jan 22No update posted to US trials registry for PIII DESTINY-Breast04 trial [6].
Jan 21PIII DESTINY-Breast04 trial is ongoing and has finished recruitment, after enrolment expanded to additional countries including the UK. Collection of primary outcome data is now due to complete Jan 23 [5].
Dec 18PIII DESTINY-Breast04 trial to compare trastuzumab deruxtecan to other treatments being used for HER2-low breast cancer that has spread to other parts of the body starts (NCT03734029). The trial will enroll 540 patients in the US, Germany & Japan. Collection of primary outcome data (PFS) is due to complete Jan 22 [2].

Evidence based evaluations

EnhertuMetastatic HER2-low, HR-positive breast cancer in patients who have progressed on endocrine therapy

Information

Enhertu
Licence extension / variation
Daiichi Sankyo
Daiichi Sankyo

Development and Regulatory status

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

Category

Antibody-drug conjugate composed of an anti-HER2 antibody, trastuzumab, and a DNA topoisomerase I inhibitor, a DX 8951 derivative. The HER2 antibody is attached to the topoisomerase I inhibitor by a tetrapeptide linker.
In 2014, there were approximately 46,500 new diagnoses of breast cancer in England. It is estimated that approximately 15-25% of women with breast cancer will have HER2-positive tumours [1].
Metastatic HER2-low, HR-positive breast cancer in patients who have progressed on endocrine therapy
Intravenous infusion

EnhertuHER2-positive gastric or gastroesophageal cancer - second-line

Information

Enhertu
Licence extension / variation
Daiichi Sankyo
Daiichi Sankyo

Development and Regulatory status

None
Phase III Clinical Trials
None

Category

Antibody-drug conjugate composed of an anti-HER2 antibody, trastuzumab, and a DNA topoisomerase I inhibitor, a DX 8951 derivative. The HER2 antibody is attached to the topoisomerase I inhibitor by a tetrapeptide linker.
Gastric cancer is the second most common cause of cancer-related death in the world. It is a difficult disease to cure, mainly because most patients present with advanced disease. Around 6,700 people are diagnosed with stomach cancer in the UK each year [2014-16 data]. Around 20% of gastric cancers are HER2 positive. The number of people in the UK diagnosed with stomach cancer has been falling over the last 10 years [1-3].
HER2-positive gastric or gastroesophageal cancer - second-line
Intravenous infusion

Enhertu Early HER2-positive high risk breast cancer - neoadjuvant therapy

Information

Enhertu
Licence extension / variation
Daiichi Sankyo
Daiichi Sankyo

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Antibody-drug conjugate composed of an anti-HER2 antibody, trastuzumab, and a DNA topoisomerase I inhibitor, a DX 8951 derivative. The HER2 antibody is attached to the topoisomerase I inhibitor by a tetrapeptide linker.
Breast cancer remains the most common cancer and is one of the leading causes of cancer-related deaths in women worldwide. More than two million cases of breast cancer are diagnosed each year, resulting in nearly 685,000 deaths globally. Approximately one in five cases of breast cancer are considered HER2 positive [1].
Early HER2-positive high risk breast cancer - neoadjuvant therapy
Intravenous infusion

Enhertu HER2-positive high-risk breast cancer - post-neoadjuvant

Information

Enhertu
Licence extension / variation
Daiichi Sankyo
Daiichi Sankyo

Development and Regulatory status

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

Category

Antibody-drug conjugate composed of an anti-HER2 antibody, trastuzumab, and a DNA topoisomerase I inhibitor, a DX 8951 derivative. The HER2 antibody is attached to the topoisomerase I inhibitor by a tetrapeptide linker.
In 2014, there were approximately 46,500 new diagnoses of breast cancer in England. It is estimated that approximately 15-25% of women with breast cancer will have HER2-positive tumours [1].
HER2-positive high-risk breast cancer - post-neoadjuvant
Intravenous infusion

Enhertu HER2-positive metastatic breast cancer - first-line, with or without pertuzumab

Information

Enhertu
Licence extension / variation
Daiichi Sankyo
Daiichi Sankyo

Development and Regulatory status

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

Category

Breast cancer remains the most common cancer and is one of the leading causes of cancer-related deaths in women worldwide. More than two million cases of breast cancer are diagnosed each year, resulting in nearly 685,000 deaths globally. Approximately one in five cases of breast cancer are considered HER2 positive [3].
HER2-positive metastatic breast cancer - first-line, with or without pertuzumab
Intravenous infusion

EnhertuNon-small cell lung cancer (NSCLC) with HER2 Exon 19 or 20 mutations - first-line monotherapy

Information

Enhertu
Licence extension / variation
Daiichi Sankyo
Daiichi Sankyo

Development and Regulatory status

None
Phase III Clinical Trials
Phase III Clinical Trials

Category

Antibody-drug conjugate composed of an anti-HER2 antibody, trastuzumab, and a DNA topoisomerase I inhibitor, a DX 8951 derivative. The HER2 antibody is attached to the topoisomerase I inhibitor by a tetrapeptide linker.
There are around 47,800 new lung cancer cases in the UK every year, around 130 every day (2015-2017). 25% of patients diagnosed with NSCLC in England in 2013-2014 had curative or palliative chemotherapy, as part of their primary cancer treatment. Mortality rates for lung cancer are projected to fall by 21% in the UK between 2014 and 2035, to 58 deaths per 100,000 people by 2035 [1].
Non-small cell lung cancer (NSCLC) with HER2 Exon 19 or 20 mutations - first-line monotherapy
Intravenous infusion