Mirvetuximab Soravtansine Sample Clauses

Mirvetuximab Soravtansine. The investigational study drug, MIRV, will be provided by ImmunoGen, at a protein concentration of 5.0 mg/mL in an aqueous pH 5.0 buffered solution. See the Investigator Xxxxxxxx for complete list of excipients.
Sample 1Sample 2
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Mirvetuximab Soravtansine. Because of its tumor specific expression and capacity to internalize small and large molecule ligands, FRα has emerged as a promising target for antibody drug conjugate (ADC) therapy. ADCs combine the specificity of mAb to tumor antigens with the extraordinary cytotoxicity of maytansine derivatives, which are potent anti-microtubule agents that target proliferating cells. MIRV is an ADC designed to target FRα. It consists of the humanized anti- FRα mAb M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4 (Figure 1).
Sample 1
Mirvetuximab Soravtansine. The selection of the Phase 3 dose of 6 mg/kg AIBW IV Q3W was based on data obtained from Study IMGN853-0401, a FIH study designed to establish the MTD and determine the recommended phase 2 dose (RP2D) of MIRV when administered IV as a single agent in adult patients with FRα-positive solid tumors who have relapsed or are refractory to standard therapies. The appropriateness of this dose and regimen in patients with PROC was further supported by the results of the Phase 3 study IMGN853-0403. For more information please see the Investigator Brochure.
Sample 1
Mirvetuximab Soravtansine. All patients receiving MIRV must receive 325-650 mg of acetaminophen/paracetamol (PO or IV), 10 mg IV dexamethasone, and 25-50 mg diphenhydramine (IV or PO) (equivalent drugs of similar drug classes is also acceptable) approximately 30 min before each infusion of MIRV. If individual patients require more intensive treatment to prevent infusion-related reactions (IRRs), investigators may modify the regimen accordingly. An antiemetic medication (eg, 5-HT3 serotonin receptor antagonists such as palonosetron, granisetron or ondansetron or appropriate alternatives) is recommended before each MIRV dose and may be used any time at the discretion of the treating physician.
Sample 1
Mirvetuximab Soravtansine related Adverse Events Table 6: Dose Modifications for Mirvetuximab Soravtansine-related Adverse Events Severity Grade (CTCAE) Dose Modifications for MIRV a Hematological Neutropenia Thrombocytopenia Nausea and Vomiting Diarrhea
Sample 1

Related to Mirvetuximab Soravtansine

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