Trastuzumab is available as a biosimilar medication. Hence an added benefit of trastuzumab emtansine in comparison with the act radiotherapy is not proven for these patients. See full prescribing information for complete boxed warning do not substitute kadcyla for or with trastuzumab. Trastuzumab emtansine is a lysinelinked adc sold commercially as kadcyla genentech, inc. In the united states, ado trastuzumab emtansine was approved specifically for treatment of her2positive metastatic breast cancer mbc in patients who have been treated previously with trastuzumab and a taxane paclitaxel or docetaxel, and who have already been treated for mbc or developed tumor recurrence within six months of adjuvant therapy. Trastuzumab emtansine is an antibodydrug conjugate adc, a combination between a monoclonal antibody and a smallmolecule drug. Kadcyla adotrastuzumab emtansine rochegenentech launch date. Highlights of prescribing information initial dose of. The developmental history of tdm1 reaches back to the 1970s when the national cancer institute sponsored a plant screening program where plantderived compounds were. Adotrastuzumab emtansine national cancer institute.
Trastuzumab emtansine binds to human epidermal growth factor 2 her2 receptors and undergoes. Trastuzumabemtansine is an antibody drug conjugate incorporating the human epidermal growth factor receptor 2 her2targeted antitumor properties of trastuzumab with the cytotoxic activity of the. 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. Trastuzumab emtansine is an antibody drug conjugate incorporating the monoclonal antibody trastuzumab and emtansine. Cost effectiveness of trastuzumab emtansine kadcyla, as. Overall survival os was significantly greater in the ado trastuzumab emtansine arm with a median os of 30. Measles, mumps and rubella vaccine, live is predicted to increase the risk of generalised infection possibly lifethreatening when given with trastuzumab emtansine. Call your doctor for medical advice about side effects. A list of drugs that interact with trastuzumab emtansine.
Trastuzumab emtansine also known as adotrastuzumab emtansine and sold under the trade name kadcyla, is an antibodydrug conjugate consisting of the humanized monoclonal antibody trastuzumab. Trastuzumab emtansine tdm1, an antibodydrug conjugate of trastuzumab and the cytotoxic agent emtansine dm1 provides benefit in patients with metastatic breast cancer that was previously treated with chemotherapy plus her2targeted therapy. Trastuzumab emtansine, a her2 antibodydrug conjugate adc is developed by genentech roche and immunogen for the treatment of cancer. Each molecule of trastuzumab emtansine consists of a single trastuzumab molecule with several molecules of dm1, a cytotoxic maytansinoid, attached. Genentech and immunogen are collaborating on the development of trastuzumab emtansine, a her2 antibodydrug conjugate that comprises genentechs trastuzumab antibody linked. 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. Adotrastuzumab emtansine kadcyla for breast cancer adotrastuzumab emtansine was approved by the fda on feb. Ado trastuzumab emtansine is in a class of medications called antibodydrug conjugates. In such cases, the guidelines recommend that adotrastuzumab emtansine be considered as subsequent therapy. Kadcyla adotrastuzumab emtansine is a new class of chemotherapy drug called an antibodydrug conjugate used to treat breast cancer. The emtansine moiety is comprised of two components, dm1, a. Rochegenentech also known as tdm1 in secondline treatment of her2positive advanced gastric cancer being conducted by the drugs codeveloper roche, did. Kadcyla adotrastuzumab emtansine is a her2targeted antibodydrug conjugate adc which contains the humanized antiher2 igg1, trastuzumab, covalently linked to the.
Monitor closely for cardiac dysfunction in patients receiving this combination. Inn similar structures search, synonyms, formulas, resource links, and other chemical information. Ado trastuzumab emtansine is usually given after other treatments have failed. Kadcyla, inntrastuzumab emtansine european medicines agency. Trastuzumab emtansine tdm1 is an antibodydrug conjugate made up of trastuzumab, stably linked to a highly potent chemotherapy dm1 derived from maytansine figure 1.
In phase 1, cohort 1 participants with mbc will receive trastuzumab emtansine tdm1 at a dose of 3. Adotrastuzumab emtansine intravenous route description. Several payment sources exist for cancer drugs in ontario, depending on the drug, disease indication, and how and where it is delivered. 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. Adotrastuzumab emtansine is an injectable therapy administered every 3 weeks. Adotrastuzumab emtansine injection is used to treat her2positive metastatic breast. A safety extension study of trastuzumab emtansine in. Medication orders, preprinted order sets, computerized order entry. Side effects of kadcyla adotrastuzumab emtansine injection. Kadcyla adotrastuzumab emtansine natl confidential and proprietary page 1 draft prepared. Efficacy has now been demonstrated in randomized trials as first line, second line, and later than the second line treatment of advanced breast cancer. Kadcyla is available as a singleuse vial containing 100 mg or 160 mg of trastuzumab. Kadcyla adotrastuzumab emtansine dosing, indications.
Trastuzumab emtansine tdm1 is an adc in which molecules of dm1, a cytotoxic microtubule polymerization inhibitor, are bound via a stable thioether linker to trastuzumab. Use caution with these agents and consider recent major changes indications and usage 1. Fda label information for this drug is available at dailymed. Tell your doctor if you have ever had an unusual or allergic reaction to trastuzumab or trastuzumab emtansine before receiving trastuzumab emtansine.
Data sources include ibm watson micromedex updated 4 may 2020, cerner multum updated 4 may 2020, wolters kluwer updated. Jan 03, 2019 our kadcyla ado trastuzumab emtansine side effects drug center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Dont confuse kadcyla with herceptin, fda says fiercepharma. This product information was approved at the time this auspar was published. Each vial contains 100 mg or 160 mg ado trastuzumab emtansine. This medicine is used both for early breast cancer and for breast cancer that has spread to other parts of the body metastatic. Jul 19, 2017 evidencebased recommendations on trastuzumab emtansine kadcyla for human epidermal growth factor receptor 2 her2. Kadcyla adotrastuzumab emtansine injection for iv use. Patients treated with trastuzumab emtansine should have her2 positive tumour. Do not substitute herceptin trastuzumab for or with ado trastuzumab emtansine. Overview trastuzumab emtansine for treating her2positive. Mar 05, 2014 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. Tell your doctor about the allergy and what signs you had. Trastuzumab emtansine is an antibody drug conjugate incorporating the human epidermal growth factor receptor 2 her2targeted antitumor properties of trastuzumab with the cytotoxic activity of the microtubuleinhibitory agent dm1.
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 dose of study therapy on the. Ado trastuzumab emtansine is used to treat a her2positive breast cancer. Kadcyla ado trastuzumab emtansine for injection, for intravenous use initial u. Kadcyla adotrastuzumab emtansine for injection, for intravenous use initial u. The logistics of an injectable therapy may make the. Kadcyla, as a single agent, is indicated for the treatment of patients with her2positive, metastatic breast cancer who previously received trastuzumab and a.
Standard cardiac function testing echocardiogram or multigated acquisition. Trastuzumab emtansine tdm1 is available in 100 mg and 160 mg vials. The emtansine moiety is comprised of two components, dm1, a microtubule inhibitor, and mcc, a thioether linker. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. This product information was approved at the time this.
The manufacturing strategy for first generation lysinelinked adcs involves conjugation of a linker moiety to free side chains of lysines on a mab, followed by an additional round of conjugation of the mablinker to a cytotoxic drug. Prior authorization protocol kadcyla adotrastuzumab emtansine. Pdf merger lite is a very easy to use application that enables you to quickly combine multiple pdfs in order to create a single document. Complete characterization of a lysinelinked antibody drug. Initial dose of 4 mgkg over 90 minute iv infusion, then 2 mgkg over. Cost effectiveness of trastuzumab emtansine kadcyla, as a. A combination study of kadcyla trastuzumab emtansine and. Trastuzumab emtansine drug bnf content published by nice. Do not substitute herceptin trastuzumab for or with adotrastuzumab emtansine. Tdm1 binds to the extracellular domain of the her2 protein and carries out the. Trastuzumab emtansine for residual invasive her2positive. Product information for auspar trastuzumab emtansine kadcyla roche products pty ltd pm20120273434 final 17 march 2014. If you have an allergy to ado trastuzumab emtansine or any other part of this drug.
This data was noted at the second interim analysis. Jan 03, 2019 kadcyla ado trastuzumab emtansine is a sterile, white to offwhite preservative free lyophilized powder in singleuse vials. The cost includes antineoplastic drugs only not antiemetics, supportive medications or consumables, unless otherwise indicated. Adotrastuzumab emtansine kadcyla breast cancer news. Tdm1 is currently being evaluated as adjuvant treatment for early. It is indicated as a single agent in patients who suffer from her2positive metastatic breast cancer and were unsuccessfully treated with trastuzumab and a.
Trastuzumab emtansine tdm1 is an antibodydrug conjugate of trastuzumab and the cytotoxic agent emtansine dm1, a maytansine derivative and microtubule inhibitor. Oct 08, 2012 in phase 1, cohort 1 participants with mbc will receive trastuzumab emtansine tdm1 at a dose of 3. Evidencebased recommendations on trastuzumab emtansine kadcyla for human epidermal growth factor receptor 2 her2. In addition, in vitro studies have shown that similar to trastuzumab, adotrastuzumab emtansine inhibits her2 receptor signaling, mediates antibodydependent cellmediated cytotoxicity and inhibits. Ado trastuzumab emtansine is also used after surgery for a certain type of breast cancer in women who have had treatment with other chemotherapy medications before surgery, but there was still cancer remaining in the tissue removed during surgery. Adotrastuzumab emtansine intravenous route description and. In addition, in vitro studies have shown that similar to trastuzumab, ado trastuzumab emtansine inhibits her2 receptor signaling, mediates antibodydependent cellmediated cytotoxicity and inhibits shedding of the her2 extracellular domain in human breast cancer cells that overexpress her2. Trastuzumab emtansine is an antibodydrug conjugate that contains trastuzumab, a humanised igg1. Trastuzumab emtansine an overview sciencedirect topics. Fda approves roches kadcyla trastuzumab emtansine, the first antibodydrug conjugate for treating her2positive metastatic breast cancer. Pdf zusammenfugen online pdf dateien zusammenfugen.
This is not a complete list of side effects and others may occur. Adotrastuzumab emtansine fails phase iiiii gatsby trial. The scottish medicines consortium has advised april 2017 that trastuzumab emtansine kadcyla is accepted for use within nhs scotland as monotherapy for the treatment of patients with human epidermal growth factor type 2 her2positive, unresectable locally advanced or metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination, and have either. Trastuzumab emtansine is a clear liquid that is injected into a vein. Adotrastuzumab emtansine adotrastuzumab emtansine kadcyla, genentech is an antiher2 monoclonal antibodydrug conjugate indicated for the treatment of her2positive breast cancer. Adotrastuzumab emtansine tdm1 is a her2antibody drug conjugate currently approved for the treatment of her2positive pretreated. Trastuzumab emtansine tras tooz ue mab em tan seen is a drug that is used to treat some types of cancer. Completed singleagent trastuzumab emtansine or combination trastuzumab emtansine treatment in the parent study or who continue to receive singleagent trastuzumab.
Dieses kostenlose tool erlaubt es mehrere pdfs oder bilddateien miteinander zu einem pdfdokument zu verbinden. Adotrastuzumab emtansine professional patient advice. Breast cancer that is her2 positive and has already been treated with a taxane and trastuzumab. Adotrastuzumab emtansine is used to treat a her2positive breast cancer. Kadcyla adotrastuzumab emtansine chemotherapy, side. Highlights of prescribing information initial dose of 4 mg. Ensure funding has been approved prior to starting treatment. Ado trastuzumab emtansine injection is used to treat her2positive metastatic breast cancer cancer that has spread in patients who have previously received other medicines eg, trastuzumab, taxane medicine that did not work well or whose cancer has returned during or within 6. Trastuzumab emtansine interactions bnf content published. Longtime response with adotrastuzumab emtansine in a. Adotrastuzumab emtansine is also used after surgery for a certain type of breast cancer in women who have had treatment with other chemotherapy medications before surgery, but there was still cancer. Trastuzumab emtansine tdm1, an antibodydrug conjugate of trastuzumab and the cytotoxic agent emtansine dm1 provides benefit in patients with metastatic breast cancer that was previously.
349 343 14 493 1237 1076 941 1237 224 709 330 1161 1327 555 297 1155 360 349 1025 81 739 204 1325 144 679 108 1030 1116 116 433 164 151 540 96 62 210 998 1106 1298 1375 1178 948 927 407 75 593 145