Rx Product News: February 2022


This month's Rx product news features Keytruda, Rituxan, and Cutaquig.

Pembrolizumab (Keytruda)

Manufactured by Merck

The FDA has approved pembrolizumab (Keytruda) for the adjuvant treatment of adult and pediatric patients with stage IIB or IIC melanoma following resection. The indication is also expanded to pediatric patients 12 years or older as an adjuvant treatment for stage III melanoma and with completely resected melanoma across stage IIB, stage IIC, and stage III. Pembrolizumab is the first anti–PD-1/anti–PD-L1 therapy that demonstrates a recurrence-free survival benefit in the adjuvant setting. The approval is based on data from the first interim analysis of the phase 3 KEYNOTE-716 trial (NCT03553836) that showed pembrolizumab reduced the risk of death or disease recurrence by 35% compared with the placebo.



Baclofen Oral Granules (Lyvispah)

Manufactured by Saol Therapeutics

The FDA has approved baclofen (Lyvispah) for the treatment of spasticity resulting from multiple sclerosis. It is indicated for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. In addition, baclofen can potentially help individuals with spinal cord disease and injuries. Lyvispah is a dissolvable, strawberry-flavored granular formulation of baclofen that is available for individuals 12 years and older. It is available in 5-, 10-, and 20-mg packets and is approved for administration with enteral feeding tubes, with
or without water, and with soft foods. The most common adverse reactions include confusion, constipation, dizziness, drowsiness, fatigue, and headaches.



Rituximab (Rituxan) With Chemotherapy

Manufactured by Genentech
The FDA has approved rituximab (Rituxan) plus chemotherapy for pediatric patients with advanced-stage, previously untreated Burkitt-like lymphoma (BLL), Burkitt lymphoma (BL), CD20-positive diffuse large B-cell lymphoma (DLBCL), or mature B-cell acute leukemia (B-AL). The approval was based on the global, open-label phase 3 Ritux 2010 trial (NCT01516580) that enrolled patients 6 months or older with advanced-stage, CD20-positive, previously untreated DLBCL, BL, BLL, or B-AL. The main efficacy outcome was event-free survival, with events defined as death from any cause, progressive disease relapse, second malignancy, or nonresponse as evident from the detection of viable cells in residue after the second cytarabine/veposide course. Individuals were administered 6 infusions of 375 mg/m2 of intravenous rituximab.




Manufactured by Octapharma

The FDA has approved Octapharma’s cutaquig, a 16.5% immune globulin solution for subcutaneous infusion, for the treatment of pediatric patients 2 years and older with primary humoral immunodeficiency (PI). It was previously approved for adults with PI. The FDA’s approval follows the results of 2 clinical trials of the drug that included adults and children aged 2 to 17 years. Individuals received weekly infusions of cutaquig during a 12-week wash-in/wash-out period, followed by a 12-month efficacy period. No bacterial infections were reported throughout the trial period. Patients should be monitored for signs and symptoms of thrombosis and have their blood viscosity assessed when at risk of hyperviscosity.



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