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FDA approves addition of overall survival data to carfilzomib label

Today the FDA has approved the supplemental New Drug Application (sNDA) to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for carfilzomib.

Data added to the label demonstrated that carfilzomib and dexamethasone (cd) reduced the risk of death by 21 percent and increased OS by 7.6 months versus bortezomib and dexamethasone (bd) in patients with relapsed or refractory multiple myeloma (median OS 47.6 months for Kd versus 40.0 months for Vd, HR=0.79; p=0.01).

The National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) list cd as the only preferred doublet regimen at relapse for multiple myeloma. Full OS results from the ENDEAVOR trial were published earlier this year in The Lancet Oncology.

Adverse events observed in this updated analysis were consistent with those previously reported for ENDEAVOR.

The most common adverse events (greater than or equal to 20 percent) in the carfilzomib arm were anaemia, diarrhoea, pyrexia, dyspnea, fatigue, hypertension, cough, insomnia, upper respiratory tract infection, peripheral edema, nausea, bronchitis, asthenia, back pain, thrombocytopenia and headache.

Since its approval in 2012, more than 50,000 patients worldwide have received carfilzomib.

The carfilzomib clinical program continues to focus on providing treatment options for physicians and patients for this frequently relapsing and difficult-to-treat cancer.

Carfilzomib is available for patients whose myeloma has relapsed or become resistant to another treatment and continues to be studied in a range of combinations and patient populations.

The randomised ENDEAVOR trial of 929 patients evaluated carfilzomib in combination with low-dose dexamethasone, versus bortezomib with low-dose dexamethasone in relapsed or refractory patients who previously received at least one, but not more than three, prior therapeutic regimens.

The primary endpoint of the trial was progression-free survival, defined as the time from treatment initiation to disease progression or death.

The primary analysis was published in The Lancet Oncology and is described in the Prescribing Information.

Patients received treatment until progression with carfilzomib as a 30-minute infusion on days 1, 2, 8, 9, 15 and 16 of 28 day treatment cycles, along with low-dose dexamethasone (20 mg).

For cycle one only, carfilzomib was administered at 20 mg/m2 on days 1 and 2, and if tolerated was escalated to 56 mg/m2 from day 8 of cycle one onwards.

Patients who received bortezomib (1.3 mg/m2) with low-dose dexamethasone (20 mg) were treated with bortezomib administered subcutaneously or intravenously at the discretion of the investigator and in accordance with regional regulatory approval of bortezomib.

More than 75 percent of the patients in the control arm received bortezomib subcutaneously.

This study was conducted at 235 sites worldwide.

For information about this trial, please visit www.clinicaltrials.gov under trial identification number NCT01568866.

For further information regarding multiple myeloma, carfilzomib toxicities and further reading click here.

Source: AMGEN

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