Gohibic Receives FDA Emergency Use Authorization
InflaRx was awarded an emergency use authorization (EUA) for Gohibic (vilobelimab) injection on April 4, 2023. It is the first in a new class of monoclonal antibodies that help to regulate immune response by inhibiting human complement factor C5a. The U.S. Food and Drug Administration (FDA) issued the EUA for treating adults who are hospitalized with severe COVID-19 and who need breathing assistance through invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). Treatment must begin no later than 48 hours after the breathing assistance starts. The recommended dose is 800mg (four vials) diluted and given as 30-to-60-minute intravenous (IV) infusions once a day on the first, second, fourth, eighth, 15th, and 22nd days. Six doses are the upper limit and Gohibic should not be continued after the patient leaves the hospital. As opposed to patients given placebo infusions, 24% more of the patients treated with Gohibic in phase III clinical trial were alive 28 days after they needed breathing assistance. All patients continued on standard COVID-19 care with anticoagulants, dexamethasone, and immunomodulators. Using Gohibic may raise the risk of infections, high blood pressure, blood clots, increased liver enzymes, reduced platelets, and irregularly fast heartbeats. Look here for a Fact Sheet on Gohibic for healthcare providers and here for patient and caregiver information.
Expanded Indication for Keytruda Plus Padcev
As an Accelerated Approval, the FDA granted a new indication on April 3, 2023, for the combination of Keytruda® (pembrolizumab – Merck) and Padcev® (enfortumab vedotin-ejfv – Astellas/Seagen). They now can be used together for treating adult patients who have urothelial (bladder) carcinoma that has spread locally or widely and that cannot be treated with cisplatin chemotherapy (chemo). According to Merck, about 9,000 new patients may be eligible for treatment with the two-drug regimen each year. Keytruda is a programmed cell death-1 (PD-1) inhibitor that enhances immune system response against tumor cells by interfering with certain receptors on T-cells. Its recommended dose for the new indication is 200mg infused IV on the first day of 21-day treatment cycles about one-half hour after Padcev has been given. Alternatively, it can be dosed at 400mg on the first day of every second cycle (once every six weeks). Padcev combines a drug with an antibody that targets Nectin-4, a protein expressed by urothelial cancer cells. For the new indication, it is administered by IV infusion on the first and eighth days of each cycle at a dose of 1.25mg/kg with a limit of 125mg/dose. Because the decision is based on interim information, it will need additional evidence from clinical trials to become fully approved. Keytruda has multiple other indications for treating various cancers, including for specific advanced urothelial cancers as a single agent. Padcev also is FDA-approved to be used as second-line or later monotherapy for urothelial cancer. Here is updated prescribing information for Keytruda and here for Padcev.
Two Indications Being Withdrawn for Imbruvica
In press releases dated April 6, 2023, AbbVie and its partner, the Janssen Pharmaceutical Companies of Johnson & Johnson, announced that they are collaborating with the FDA to retract Accelerated Approvals for Imbruvica® (ibrutinib) for the treatment of mantle cell lymphoma (MCL) and marginal zone lymphoma (MZL). Required clinical trials to support the interim results that prompted the approvals did not confirm its clinical benefit for the two cancers. With FDA oversight, both companies will consult with healthcare providers to determine the best options for patients currently being treated with Imbruvica for MCL or MZL. First approved by the FDA in November 2013, Imbruvica is an oral Bruton’s tyrosine kinase (BTK) inhibitor that helps to restrict the production of cancerous B cells. It retains full FDA approval for treating chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), Waldenström’s macroglobulinemia (WM), and chronic graft-versus-host disease (cGvHD). The revised prescribing information will be posted here.