FDA D.I.S.C.O. Burst Edition: FDA approvals of Cytalux (pafolacianine) for identifying malignant ovarian cancer lesions and Darzalex Faspro (daratumumab + hyaluronidase-fihj), Kyprolis (carfilzomib) and dexamethasone for multiple myeloma
Welcome back to the D.I.S.C.O., FDA’s Drug Information Soundcast in Clinical Oncology, Burst Edition, brought to you by FDA’s Division of Drug Information in partnership with FDA’s Oncology Center of Excellence. Today we’ll provide a quick update on two recent FDA cancer drug approvals.
On November 29, 2021, the FDA approved pafolacianine (brand name Cytalux), an optical imaging agent, for adult patients with ovarian cancer as an adjunct for interoperative identification of malignant lesions. Pafolacianine is a fluorescent drug that targets folate receptor which may be overexpressed in ovarian cancer. It is used with a Near-Infrared fluorescence imaging system cleared by the FDA for specific use with pafolacianine.
Efficacy was evaluated in a single arm, multicenter, open-label study of 178 women diagnosed with ovarian cancer or with high clinical suspicion of ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery. All patients received pafolacianine. One hundred and thirty-four patients received fluorescence imaging evaluation in addition to standard of care evaluation which includes pre-surgical imaging, intraoperative palpation and normal light evaluation of lesions. Among these patients, 36 had at least one evaluable ovarian cancer lesion detected with pafolacianine that was not observed by standard visual or tactile inspection. The patient-level false positive rate of pafolacianine with Near-Infrared fluorescent light with respect to the detection of ovarian cancer lesions confirmed by central pathology was 20.2%.
The most common adverse reactions occurring in more than 1% of patients were nausea, vomiting, abdominal pain, flushing, dyspepsia, chest discomfort, pruritus, and hypersensitivity.
On November 30, 2021, the FDA approved daratumumab + hyaluronidase-fihj (brand name Darzalex Faspro) and carfilzomib (brand name Kyprolis) plus dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received 1 to 3 prior lines of therapy.
Efficacy was evaluated in a single-arm cohort of PLEIADES, a multi-cohort, open-label trial. This cohort enrolled 66 patients with relapsed or refractory multiple myeloma who received at least one prior line of therapy. Patients received Darzalex Faspro administered subcutaneously in combination with Kyprolis and dexamethasone.
The main efficacy outcome measure was overall response rate. The overall response rate was 84.8%. At a median follow-up of 9.2 months, the median duration of response had not been reached and an estimated 85.2% maintained response for at least 6 months and 82.5% maintained response for at least 9 months.
The most common adverse reactions occurring in more than 20% of patients treated with Darzalex Faspro, Kyprolis, and dexamethasone were upper respiratory tract infections, fatigue, insomnia, hypertension, diarrhea, cough, dyspnea, headache, pyrexia, nausea, and edema peripheral.
This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.
Full prescribing information for these approvals can be found on the web at www.fda.gov/drugsatFDA.
Health care professionals should report serious adverse events to FDA’s MedWatch Reporting Program at www.fda.gov/medwatch.
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