Kadcyla Trastuzumabum emtansinum 160 mg
For a drug company with a product on the market, investors have to balance valuations in terms of sales of existing products with the development of new products that will drive future growth.
ImmunoGen's (NASDAQ:IMGN) valuation comes almost entirely from the latter. In its first fiscal quarter ending on September 30, the biotech received only $4.2 million in royalty payments from Roche for sales of the cancer drug Kadcyla.
Fortunately, the company's pipeline is fairly packed. ImmunoGen's partners have eight drugs in clinical trials using its antibody drug conjugate technology, and the biotech expects more to enter next year.
Severe adverse reactions have been reported in clinical studies with KADCYLA. Before beginning treatment with KADCYLA, review the Preadministration Guidelines and the Dose Modifications and Reductions Guidelines, which can be found in the accompanying full Prescribing Information. For an additional resource, download the Dosing and Administration Guide.
Dose reductions should be made in decrements of 0.6 mg/kg
A maximum of 2 dose reductions should occur before discontinuation
Hepatotoxicity, predominantly in the form of asymptomatic increases in the concentrations of serum transaminases, has been observed in clinical trials with KADCYLA.
Serious hepatobiliary disorders, including at least 2 fatal cases of severe drug-induced liver injury and associated hepatic encephalopathy, have been reported in clinical trials with KADCYLA. Some of the observed cases may have been confounded by comorbidities and concomitant medications with known hepatotoxic potential.
Patients treated with KADCYLA are at increased risk of developing left ventricular dysfunction. A decrease of LVEF to 40% has been observed in patients treated with KADCYLA. In EMILIA, left ventricular dysfunction occurred in 1.8% of patients in the KADCYLA-treated group and 3.3% of patients in the comparator group.
Assess LVEF prior to initiation of KADCYLA and at regular intervals (eg every 3 months) during treatment. Treatment with KADCYLA has not been studied in patients with LVEF 50% prior to treatment. If, at routine monitoring, LVEF is 40%, or is 40% to 45% with a 10% or greater absolute decrease below the pretreatment value, withhold KADCYLA and repeat LVEF assessment within approximately 3 weeks. Permanently discontinue KADCYLA if the LVEF has not improved or has declined further.
KADCYLA is approved to treat HER2-positive breast cancer that has spread to other parts of the body (metastatic breast cancer) after prior treatment with trastuzumab (Herceptin®) and a taxane. Prior treatment could have been for the initial treatment of cancer that had spread to other parts of the body.
Liver problems: ADCYLA may cause severe liver problems that can be life-threatening. Symptoms of liver problems may include vomiting, nausea, eating disorder (anorexia), yellowing of the skin (jaundice), stomach pain, dark urine, or itching
Heart problems: KADCYLA may cause heart problems, including those without symptoms (such as reduced heart function) and those with symptoms (such as congestive heart failure). Symptoms may include swelling of the ankles or legs, shortness of breath, cough, rapid weight gain of greater than 5 lbs in less than 24 hours, dizziness or loss of consciousness, or irregular heart beat
Pregnancy Receiving KADCYLA during pregnancy can result in the death of an unborn baby and birth defects. Birth control should be used while you receive KADCYLA and for 7 months after your last dose of KADCYLA.
