Breast cancer that is her2 positive and has already been treated with a taxane and trastuzumab. Description of first aid measures eye contact rinse immediately with tap water for 10 minutes open eyelids forcibly skin contact remove immediately contaminated clothes, wash affected skin with water and soap do not use any. Here are links to possibly useful sources of information about trastuzumab emtansine. Trastuzumab emtansine tdm1 is an antibodydrug conjugate made up of trastuzumab, stably linked to a highly potent chemotherapy dm1 derived from maytansine figure 1. Trastuzumab emtansine binds to her2 and triggers the sam e anti tumour activity as trastuzumab including suppression of her2 signalling pathways, her2 extracellular domain ecd shedding, and mediation of antibody dependent cell mediated cytotoxicity. As compared to the combination lapatinib and capecitabine treatment arm, patients randomized to ado trastuzumab emtansine had statistically significant improvements in the coprimary.
A study of trastuzumab emtansine in participants with human. Ado trastuzumab emtansine induced pulmonary toxicity. Tdm1 is currently being evaluated as adjuvant treatment for early. Tdm1 had less severe toxicity than lapatinib plus capecitabine. Hence an added benefit of trastuzumab emtansine in comparison with the act radiotherapy is not proven for these patients. Trastuzumab emtansine binds to human epidermal growth factor 2 her2 receptors and undergoes. Adotrastuzumab emtansine adotrastuzumab emtansine kadcyla, genentech is an antiher2 monoclonal antibodydrug conjugate indicated for the treatment of her2positive breast cancer. Trastuzumab emtansine drug bnf content published by nice. Highlights of prescribing information initial dose of 4. Fda approves adotrastuzumab emtansine for early breast. The developmental history of tdm1 reaches back to the 1970s when the national cancer institute sponsored a plant screening program where plantderived compounds were. Trastuzumab emtansine is then internalised and degraded to dm1 containing cytotoxic. Tell your doctor if you have ever had an unusual or allergic reaction to trastuzumab. Trastuzumab emtansine for her2positive breast cancer.
Trastuzumab emtansine, an antibodydrug conjugate commonly abbreviated as tdm1, improved overall survival for women and men with her2positive metastatic breast cancer that had progressed after treatment with other her2targeted drugs. Use caution with these agents and consider recent major changes. Kadcyla access solutions kadcyla adotrastuzumab emtansine. Antibodydrug conjugates adcs are a means to deliver cytotoxic drugs specifically to cancer cells. Adotrastuzumab emtansine is the generic name for kadcyla. In a phase iii trial of 602 women with advanced her2positive breast cancer whose cancer recurred or progressed despite previous treatments, those given genentechs kadcyla tdm1, ado trastuzumab emtansine achieved median progression free survival pfs of 6.
Kadcyla trastuzumab emtansine tras tooz ue mab em tan seen is a drug that is used to treat some types of cancer. Jul 14, 20 trastuzumab emtansine is a unique antibodydrug conjugate targeting selectively human epidermal growth factor receptor 2 her2 positive breast cancer cells, thus conferring high efficacy with minimal systemic toxicities. Trastuzumab emtansine interactions bnf content published. The success story of trastuzumab emtansine, a targeted. Ado trastuzumab emtansine is used to treat a her2positive breast cancer. Researchers are investigating if the drug has potential in a number of other indications, including gastric and lung cancer.
Ado trastuzumab emtansine is currently approved by the u. Selected laboratories need to be proficient with ihc and fish technology to ensure reliable results. Cost effectiveness of trastuzumab emtansine kadcyla, as a. The delivery is followed by internalization of the adc and release of free, highly active cytotoxic agents within cancer cells, leading eventually to cell death. Fda label information for this drug is available at dailymed. Other considerations her2 testing is essential to determine if patients are appropriate for adotrastuzumab emtansine therapy. Initial dose of 4 mgkg over 90 minute iv infusion, then 2 mgkg over. Dm1, the cytotoxic component of kadcyla adotrastuzumab emtansine, can be expected to cause embryo. Trastuzumab emtansine tdm1, an antibodydrug conjugate, prolonged disease free survival compared to lapatinib plus capecitabine in her2positive breast cancer. Lyophilized powder in single kadcyla adotrastuzumab emtansine for injection, for intravenous use initial u.
Trastuzumab herceptin, adotrastuzumab kadcyla and pertuzumab perjeta page 1 of 31 05062015. Trastuzumab emtansine benefit assessment according to 35a social. Treatment of patients with her2 positive metastatic breast cancer who received both prior treatment with trastuzumab and a taxane separately or in combination. Definition from the nci drug dictionary detailed scientific definition and other names for this drug. Lyophilized powder in single kadcyla ado trastuzumab emtansine for injection, for intravenous use initial u. Kadcyla adotrastuzumab emtansine dosing, indications. Trastuzumab emtansine tdm1 is an antibodydrug conjugate that is. A list of drugs that interact with trastuzumab emtansine. This trial showed improved progressionfree survival in patients treated with trastuzumab emtansine median 9. Trastuzumab emtansine consists of a monoclonal antibody trastuzumab and potent cytotoxic agent dm1, combined together through a stable thioether bond. Trastuzumab alone stops growth of cancer cells by binding to the her2 receptor, whereas. Kadcyla is available as a singleuse vial containing 100 mg or 160 mg of trastuzumab. Trastuzumab emtansine also known as adotrastuzumab emtansine and sold under the trade. A safety extension study of trastuzumab emtansine in.
Patients treated with trastuzumab emtansine should have her2 positive tumour status. Trastuzumab herceptin, kanjinti, ogivri, trazimera, ado. Trastuzumab emtansine prolongs diseasefree survival in her2. Pdf adotrastuzumab emtansineinduced pulmonary toxicity.
Ado trastuzumab emtansine is usually given after other treatments have failed. See full prescribing information for complete boxed warning do not substitute kadcyla for or with trastuzumab. Ado trastuzumab emtansine is also being studied in the treatment of other types of cancer. Kadcyla is a prescription medicine used as an adjuvant after surgery treatment for her2positive early breast cancer when the patient has taken neoadjuvant before surgery treatment including a taxane and trastuzumab herceptin and there is cancer remaining in the tissue removed during surgery. Trastuzumab emtansine also known as ado trastuzumab emtansine and sold under the trade name kadcyla, is an antibodydrug conjugate consisting of the humanized monoclonal antibody trastuzumab herceptin covalently linked to the cytotoxic agent dm1. Adotrastuzumab emtansine is an antiher2 monoclonal antibody combined with a microtubular inhibitor. Adotrastuzumab emtansine professional patient advice. Oct 29, 2008 completed singleagent trastuzumab emtansine or combination trastuzumab emtansine treatment in the parent study or who continue to receive singleagent trastuzumab emtansine or combination trastuzumab emtansine treatment at the time of the parent study closure and received the last study drug dose within the 6 weeks 42 days prior to the first. Australian public assessment for trastuzumab emtansine.
Longtime response with adotrastuzumab emtansine in a. Learn about kadcyla access solutions, a resource that provides reliable, effective access and reimbursement support to assist your patients and practice after kadcyla adotrastuzumab emtansine has been prescribed. Mar 19, 2020 reduce the dose or discontinue ado trastuzumab emtansine as appropriate in cases of increased serum transaminases or total bilirubin. Trastuzumab emtansine is a clear liquid that is injected into a vein. Trastuzumab emtansine or ado trastuzumab emtansine tdm1 is an adc with the her2targeted antitumor properties of trastuzumab and the cytotoxic activity of the microtubuleinhibitory agent dm1 attached via a stable thioethel linker. Adotrastuzumab emtansine fails phase iiiii gatsby trial. Oct 08, 2012 a study of trastuzumab emtansine in participants with human epidermal growth factor receptor 2 her2positive breast cancer who have received prior antiher2 and chemotherapybased treatment the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Adotrastuzumab emtansine chemotherapy drug information. Trastuzumab emtansine tdm1 is an antibodydrug conjugate that is effective and generally well tolerated when administered as a single agent to treat advanced breast cancer.
The emtansine moiety is comprised of two components, dm1, a microtubule inhibitor, and mcc, a thioether linker. Kadcyla adotrastuzumab emtansine for injection, for intravenous use initial u. Kadcyla adotrastuzumab emtansine injection for iv use. A1401 trastuzumab extract of dossier assessment iqwig. We report a case of recurrent metastatic breast cancer with unusually lengthy progressionfree survival pfs on tdm1 chemotherapy. Trastuzumab herceptin, ado trastuzumab kadcyla and pertuzumab perjeta number. Article information, pdf download for adotrastuzumab emtansine. Product information for auspar trastuzumab emtansine kadcyla roche products pty ltd pm20120273434 final 17 march 2014. Trastuzumab emtansine for residual invasive her2positive. Trastuzumab emtansine in residual breast cancer residual cancer after induction therapy for her2positive breast cancer is associated with a worse. In this summary we report the results of the costeffectiveness analyses of trastuzumab emtansine compared to the primary and secondary comparators.
Food and drug administration fda for treatment of metastatic, her2positive breast cancer that has grown despite other her2targeting treatments. Aetna considers ado trastuzumab emtansine experimental and investigational for all other indications e. Ado trastuzumab emtansine administration may lead to reductions in left ventricular ejection fraction lvef. This product information was approved at the time this auspar was published. Trastuzumab emtansine is an antibody drug conjugate incorporating the monoclonal antibody trastuzumab and emtansine.
Kadcyla ado trastuzumab emtansine for injection, for intravenous use initial u. Kadcyla is a her2targeted antibody and microtubule inhibitor conjugate. Do not substitute herceptin trastuzumab for or with ado trastuzumab emtansine. Participants receiving singleagent trastuzumab emtansine or trastuzumab emtansine administered in combination with other anticancer therapies in a genentech rochesponsored parent study who are active and receiving benefit at the closure of parent study are eligible for continued treatment in this study. Kadcyla, inntrastuzumab emtansine european medicines agency. Trastuzumab emtansine an overview sciencedirect topics. Trastuzumab emtansine is an antibodydrug conjugate adc, a combination between a monoclonal antibody and a smallmolecule drug. Trastuzumab emtansine is recommended, within its marketing authorisation, as an option for treating human epidermal growth factor receptor 2 her2positive, unresectable, locally advanced or metastatic breast cancer in adults who previously received trastuzumab and a taxane, separately or in combination. Trastuzumab emtansine for treating her2positive advanced. Statement on a nonproprietary name adopted by the usan council. In some cases, health care professionals may use the generic name adotrastuzumab emtansine when referring to the trade drug name kadcyla. Thereconstituted solution should be clear to slightly opalescent and free of visible. Administer kadcyla as an intravenous infusion only with a 0. Each molecule of trastuzumab emtansine consists of a single trastuzumab molecule with several molecules of dm1, a cytotoxic maytansinoid, attached.
Measles, mumps and rubella vaccine, live is predicted to increase the risk of generalised infection possibly lifethreatening when given with trastuzumab emtansine. Mar 05, 2014 trastuzumab emtansine, a her2targeted antibodydrug conjugate. On may 3, 2019, the food and drug administration approved ado trastuzumab emtansine kadcyla, genentech, inc. Adotrastuzumab emtansine national cancer institute. Pdf 326peffectiveness of trastuzumab emtansine tdm1 in. The reconstituted solution should be clear to slightly opalescent and free of visible.
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