FDA Approvals Roundup: Cytalux, Lyvispah, Caldolor

RoundupsRoundups | 01 December 2021 |  By 

A weekly update on new drug approvals and indications from the US Food and Drug Administration (FDA).
New approvals
Cytalux okayed for aiding identification of ovarian cancer lesions during surgery
On Target Laboratories’ Cytalux (pafolacianine) has been approved as a diagnostic agent in assisting surgeons identify cancerous lesions in women with ovarian cancer.
The intravenous imaging drug is administered before surgery to improve detection of additional, difficult-to-detect ovarian cancerous tissue during surgery.
The approval was based on findings from a randomized, multicenter, open-label study of 134 women from the indicated population who received Cytalux pre-operatively and were evaluated under normal and fluorescent light during surgery. In all, 26.9% of the women had at least one cancerous lesion that had not been detected by standard visual or tactile inspection.
Cytalux was granted priority review and received orphan drug and fast track designations.
Lyvispah cleared for treating spasticity in patients with multiple sclerosis 
Saol’s Lyvispah (baclofen oral granules) has been approved for treating spasticity in adults with multiple sclerosis, especially for relief of flexor spasms and concomitant pain, involuntary and rhythmic muscle contractions, and muscular rigidity. It may also be of some value in patients with spinal cord injuries and other spinal cord diseases.
The approval was supported by efficacy findings in a bioavailability study in healthy adults comparing Lyvispah oral granules and baclofen oral tablets.
New indications
Caldolor use extended for pre-operative administration for pain relief
Cumberland’s Caldolor (ibuprofen injection) has been granted expanded use for pre-operative administration so that patients wake up with significantly less pain.
The approval was supported by findings from a multicenter, randomized, double-blind, placebo-controlled study of orthopedic surgical pain in 185 patients randomized to receive pre-operative Caldolor or placebo, with supplemental morphine on an as-needed basis. Patients receiving the study drug experienced a statistically significant greater reduction in pain intensity during the 24 hours after surgery compared with those receiving placebo.
The nonnarcotic pain reliever was originally approved in 2009 for managing pain and reducing fever in adults and children aged 6 months or older. It carries a boxed warning for risk of serious cardiovascular and gastrointestinal events.
Tpoxx gets new dosing regimen for smallpox
Siga’s Tpoxx (tecovirimat capsules) has received approval for a new dosing regimen to treat smallpox disease in adult and pediatric patients weighing 120 kg or more. The drug was originally approved in 2018 for treating smallpox in adults and children weighing at least 13 kg.
Darzalex Faspro plus carfilzomib gets green light for advanced multiple myeloma
Janssen Biotech’s Darzalex Faspro (daratumumab plus hyaluronidase-fihj injection), combined with Amgen’s Kyprolis (carfilzomib) plus dexamethasone, has received a new indication for treating relapsed or refractory multiple myeloma in previously treated adults.
The approval was based on findings from a single-arm cohort of the multicohort, open-label PLEIADES trial in which 66 patients from the indicated population received Darzalex Faspro plus carfilzomib and dexamethasone until disease progression or unacceptable toxicity. Overall response rate was 84.8%. Median duration of response had not been reached at the median follow-up of 9.2-months. Of responders, 85.2% maintained response for at least 6 months and 82.5%, for at least 9 months.
The review used FDA’s Oncology Center of Excellence’s Assessment Aid, which is a voluntary submission based on FDA’s multidisciplinary review template intended to improve the efficiency and consistency of reviews.
Darzalex Faspro was originally approved in 2020, in combination with other drugs, for treating adults with multiple myeloma.



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Tags: FDA, US

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