Trazimera, INN-TRASTUZUMAB - European Medicines Agency

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TRAZIMERA. TM (trastuzumab-qyyp) for injection, for intravenous use Initial U.S. Approval: 2019 . TRAZIMERA TRAZIMERA as a lyophilized, sterile powder or cake. Route of Administration Intravenous infusion Herceptin vs US-licensed Herceptin 114.2 (105.1, 124.2) Abstract. Background: Trazimera™ (PF-05280014) is a trastuzumab biosimilar. This multinational, randomized, double-blind, parallel-group study (NCT01989676) compared Trazimera with reference trastuzumab (Herceptin ®) sourced from the EU (Herceptin-EU), each plus paclitaxel, in the first-line treatment of HER2-positive metastatic breast cancer (MBC).

Förmån: Ingen förpackning har förmån. Recept: Receptbelagt. Försäkring: Läkemedlet omfattas av Tegsedi (inotersen), avsett för behandling av familjär transtyretinamyloidos. Trazimera (trastuzumab), biosimilar avsett för behandling av bröst- och magcancer.

14 Mar 2019 Trazimera (trastuzumab-gyyp) was approved by the US Food and Drug Administration (FDA) for the treatment of HER2 positive breast cancer 11 Mar 2019 The U.S. Food and Drug Administration said on Monday it approved Pfizer a year after the agency declined to approve the drug, Trazimera, and sought Herceptin is one of Roche's top drugs and brought in sales of 7 Feb 2020 Avastin, Herceptin, and Rituxan, at significantly discounted prices, of Roche's Herceptin (trastuzumab), under the brand name Trazimera, 24 Jan 2020 biosimilar versions of Roche's cancer drugs Avastin and Rituxan in plans to launch Trazimera, a biosimilar version of Roche's Herceptin 1 Aug 2018 European Commission (EC) has approved Pfizer's Trazimera, for breast and gastric cancer treatment, marking it as pharma's first oncology 12 Mar 2019 The Food and Drug Administration has approved Trazimera (trastuzumab-qyyp), a biosimilar of Herceptin (trastuzumab), for the treatment of 27 Jan 2020 Trazimera, Pfizer, Herceptin, No (scheduled for Feb. Over the first nine months of 2019, revenue from Herceptin and Rituxan was about $1 early breast cancer (when the cancer has spread within the breast or to the glands under the arm but not to other parts of the body) after surgery, chemotherapy 25 Sep 2018 up to a half of patients do not receive trastuzumab or any other HER2-targeted agent, mainly due Trazimera/Pfizer Europe MA EEIG.

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Adjuvant Treatment of HER2-Overexpressing Breast Cancer. Administer at 11 Mar 2019 Trazimera, Ontruzant, Herzuma, Ogivri, and Herceptin share the following indications: — Adjuvant breast cancer: adjuvant treatment of HER2 12 Mar 2019 It has been given the designation trastuzumab-gyyp and is indicated for breast cancers and metastatic gastric or gastroesophageal junction In combination with doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel. Herceptin, Ogivri, Herzuma, Ontruzant, Trazimera, Kanjinti; 4 mg/kg IV 31 Dec 2020 00069-0305-XX TRAZIMERA 420MG Solution Reconstituted (PFIZER trastuzumab-pkrb (Herzuma®) and Trastuzumab-qyyp (Trazimera™). TRAZIMERA alone is approved for the treatment of HER2+ breast cancer in patients who have received one or more chemotherapy courses for metastatic disease.

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Metastatic Gastric Cancer. TRAZIMERA is approved, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2+ metastatic cancer of the stomach or gastroesophageal junction (where the esophagus meets the stomach) in patients who have not received prior treatment for their metastatic disease. The FDA has approved Pfizer’s trastuzumab-qyyp (Trazimera), a biosimilar referencing Herceptin. "This is an important milestone in the [United States] which both adds to our growing portfolio of oncology treatments and has the potential to improve access to cancer care,” said Andy Schmeltz, global president of Pfizer Oncology, in a statement. 2020-08-20 TRAZIMERA is a monoclonal antibody (mAb) biosimilar of the originator biologic medicine, Herceptin, which targets HER2, a protein found on the surface of some cancer cells which can stimulate the cells to divide and grow. 11 TRAZIMERA locks on to the HER2 protein and blocks the receptors, stopping cell division and growth.
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2019-03-12 · In addition, there were no clinically meaningful differences noted between Trazimera and Herceptin in terms of efficacy, safety, immunogenicity, and noninferiority in pharmacokinetics when used for The approval is based on research showing that Trazimera is as effective and as safe as Herceptin. Trazimera side effects. Like Herceptin, Trazimera can cause side effects, some of them severe. Common Trazimera side effects include: headache diarrhea nausea chills fever infection congestive heart failure insomnia cough rash TRAZIMERA is a trademark of Pfizer Inc. Herceptin is a registered trademark of Genentech, Inc. The FDA has approved Pfizer’s trastuzumab-qyyp (Trazimera), a biosimilar referencing Herceptin.

Trazimera is used to treat certain types of breast cancer or stomach cancer, sometimes in combination with other cancer medicines. Trazimera is sometimes used when the cancer has spread to other parts of the body (metastatic). Trazimera may also be used for purposes not listed in this medication guide.
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Pfizer Medical Information Sweden

CSA Schedule** 2019-03-12 2019-09-27 Trazimera, Biosimilar to Herceptin, Gains Approval The FDA approved trastuzumab- qyyp (Trazimera, Pfizer), a biosimilar to Herceptin (Genentech) for the treatment of HER2-overexpressing breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. Metastatic Gastric Cancer. TRAZIMERA is approved, in combination with chemotherapy (cisplatin and either capecitabine or 5-fluorouracil), for the treatment of HER2+ metastatic cancer of the stomach or gastroesophageal junction (where the esophagus meets the stomach) in patients who have not received prior treatment for their metastatic disease. The FDA has approved Pfizer’s trastuzumab-qyyp (Trazimera), a biosimilar referencing Herceptin. "This is an important milestone in the [United States] which both adds to our growing portfolio of oncology treatments and has the potential to improve access to cancer care,” said Andy Schmeltz, global president of Pfizer Oncology, in a statement. 2020-08-20 TRAZIMERA is a monoclonal antibody (mAb) biosimilar of the originator biologic medicine, Herceptin, which targets HER2, a protein found on the surface of some cancer cells which can stimulate the cells to divide and grow. 11 TRAZIMERA locks on to the HER2 protein and blocks the receptors, stopping cell division and growth.

12 Mar 2019 The US Food and Drug Administration (FDA) has approved Trazimera, Pfizer's version of Roche cancer drug Herceptin (trastuzumab). 14 Mar 2019 Trazimera (trastuzumab-gyyp) was approved by the US Food and Drug Administration (FDA) for the treatment of HER2 positive breast cancer 12 Mar 2019 and Drug Administration (FDA) has approved TRAZIMERA™ (trastuzumab- qyyp), a biosimilar to Herceptin® (trastuzumab),1 for the treatment 12 Mar 2019 Pfizer has secured approval from the US Food and Drug Administration (FDA) for its Trazimera (trastuzumab-qyyp), an oncology biosimilar to 23 Apr 2019 However, Mylan20 and Pfizer21 have reached licensing agreements with Genentech to market Ogivri and Trazimera, respectively.