FDA Approves Label Update for CAR-T Cell Therapy, Yescarta

February 03, 2022 - FDA recently approved an update to the prescribing information for Kite’s Yescarta to include prophylactic corticosteroids across all approved indications.

The agency first approved Yescarta in October 2017 to treat adult patients with certain types of large B-cell lymphoma who did not respond or relapsed after at least two kinds of other treatments.

Now, Yescarta is the first and only chimeric antigen receptor (CAR) T-cell therapy with information on the label to help physicians manage and potentially prevent treatment side effects.

“These new data will enable doctors to more easily and confidently manage treatment for patients,” Frank Neumann, MD, PhD, global head of clinical development at Kite, said in the announcement.

“Since the first approval of Yescarta, Kite has worked closely with physicians to optimize all aspects of CAR T-cell therapy to enable as many patients as possible to have the chance to benefit from this treatment,” Neumann continued.

FDA based its decision on results from a new safety management cohort of the pivotal ZUMA-1 study, which assessed the impact of prophylactic use of corticosteroids and earlier treatment with corticosteroids and prophylactic levetiracetam on the incidence and severity of cytokine release syndrome (CRS) and neurologic events.

In the study, 68 percent of patients had no CRS or neurologic events within 72 hours of Yescarta infusion. Notably, no major side effects were reported in patients who received the drug, compared to 13 percent in the placebo group.

Patients can currently access Kite’s CAR-T cell therapies through 111 authorized treatment centers across the US.

FDA Approves Roche’s Macular Degeneration Drug

FDA recently approved Roche’s Vabysmo (faricimab-svoa) to treat neovascular or “wet” age-related macular degeneration (nAMD) and diabetic macular edema (DME).

Vabysmo is now the first and only approved injectable eye medicine for nAMD and DME that improves and maintains vision with treatments from one to four months apart in the first year, following four initial monthly doses.

“Vabysmo represents an important step forward for ophthalmology. It is the first bispecific antibody approved for the eye and a major advance in treating retinal conditions such as neovascular AMD and diabetic macular edema,” Charles Wykoff, MD, PhD, director of research at Retina Consultants of Texas and a Vabysmo Phase 3 trial investigator, said in the announcement.  

Neovascular AMD and DME are two leading causes of vision loss globally.

Vabysmo targets and inhibits two disease pathways linked to various vision-threatening retinal conditions by neutralizing angiopoietin-2 and vascular endothelial growth factor-A. 

FDA based its approval on positive results from four Phase 3 studies in nAMD and DME.

In all studies, Vabysmo achieved non-inferior vision gains versus aflibercept given two months in the first year. The drug was well tolerated in all studies as well. Roche stated that it will continue to initiate long-term studies for Vabysmo in individuals with nAMD and DME.

FDA Approves AbbVie’s Psoriatic Arthritis Drug

FDA recently approved AbbVie’s Skyrizi (risankizumab-rzaa) to treat adults with active psoriatic arthritis (PsA).

The agency based its approval on two pivotal studies, KEEPsAKE-1 and KEEPsAKE-2, which evaluated the safety and efficacy of Skyrizi in adults with active PsA who responded inadequately or were intolerant to other treatment options.

Skyrizi met the primary endpoint of ACR20 response at week 24 compared to placebo across both studies. The drug also demonstrated significant improvements across several other manifestations of PsA, including swollen and painful joints.

“Patients often do not suspect a connection between their psoriasis skin symptoms and the joint pain, swelling and stiffness they may be experiencing, potentially leading to a delay in diagnosis and treatment of psoriatic arthritis,” Thomas Hudson, MD, senior vice president of research and development and chief scientific officer at AbbVie, said in the announcement.

“We’re proud to expand the use of SKYRIZI to patients with psoriatic arthritis who are living with the debilitating combination of skin and joint symptoms,” Hudson continued.

Skyrizi is an interleukin-23 (IL-23) inhibitor that blocks IL-23 by binding to its p19 subunit. IL-23, a cytokine involved inflammatory process, may be linked to various chronic immune-mediated diseases, including psoriasis.

Notably, Skyrizi maintains a dosing regimen for PsA consistent with the existing regimen for moderate to severe plaque psoriasis patients.