Kineret Receives an Emergency Use Authorization

The U.S Food and Drug Administration (FDA) awarded an emergency use authorization (EUA) to Swedish Orphan Biovitrum (Sobi) for Kineret^® (anakinra) injection, on Nov. 8, 2022. Already fully approved for second-line treatment of adults who have rheumatoid arthritis (RA), it also has indications for two rare conditions, neonatal-onset multisystem inflammatory disease (NOMID) and deficiency of interleukin-1 receptor (IL-1R) antagonist (DIRA). Its EUA allows Kineret to be used as therapy for adults who are hospitalized with COVID-19, who has pneumonia, who need supplemental oxygen, who have increased blood levels of plasma soluble urokinase plasminogen activator receptor (suPAR), and who have high risks of respiratory failure. It is administered by subcutaneous (SC) injections at 100mg once a day for 10 days. Blood counts for patients who receive Kineret should be monitored because it may decrease neutrophils, a type of white blood cells that help to resist infections. Here is a Kineret Fact Sheet for healthcare providers; here is one for patients and their caregivers.

Expanded Indication for Libtayo

A non-small cell lung cancer (NSCLC) indication for Libtayo^® (cemiplimab-rwlc) injection, was extended by the FDA on Nov. 8, 2022. A programmed cell death protein-1 (PD-1) receptor inhibitor marketed by Regeneron, Libtayo now is approved along with a platinum-containing chemotherapy (chemo) regimen for the initial treatment of adults who have metastatic NSCLC that does not have mutations in the genes for epidermal growth factor receptor (EGFR), anaplastic lymphoma receptor tyrosine kinase (ALK) or the receptor tyrosine kinase, ROS1. Such NSCLC that cannot be removed surgically and that is not expected to respond to common chemo/radiation treatments may be appropriate for Libtayo/chemotherapy, whether or not it tests positive for PD-1. In the phase III clinical trial of over 460 patients, overall survival (OS) for patients given Libtayo and chemo averaged nine months longer than OS for patients receiving just chemo (22 months opposed to 13 months). The combination produced at least partial results for 43% of patients compared with 23% of patients in the chemo-only group. Adverse events that affected higher percentages of patients in the Libtayo/chemo group were nausea (25% vs 16%), peripheral neuropathy (23% vs 19%), fatigue (23% vs 18%), and reduced appetite (17% vs 12%). Previous FDA-approved indications for Libtayo include for patients who have some types of cutaneous squamous cell carcinoma (CSCC) or basal cell carcinoma (BCC), as well as for initial monotherapy to treat NSCLC that expresses 50% or more PD-L1. For all of its indications, the recommended dose is 350mg (one vial) diluted and infused intravenously (IV) over a half hour once every three weeks. Revised prescribing information is here.

Combination of AstraZeneca Drugs Granted a New Indication

Also for the treatment of adults who have metastatic NSCLC without EGFR, ALK, or ROS1 mutations, AstraZeneca announced on Nov. 11, 2022, that the FDA has approved the combination of Imfinzi^® (durvalumab) injection and Imjudo^® (tremelimumab-actl) injection. They, too, will be used along with chemo that includes a platinum-containing drug. Both are administered by IV infusions. For the new indication, Imfinzi, a PD-L1 inhibitor immunotherapy, will be given once every three weeks, along with Imjudo and chemo, for four cycles. Then it will be administered by itself once every four weeks. The dose depends on the patient’s weight — with 1,500mg/dose recommended for those who weigh 30kg (66 pounds) or more and 20mg/kg for patients weighing less. First FDA approved last month, Imjudo is a cytotoxic T-lymphocyte–associated antigen 4(CTLA-4) inhibitor that blocks the activity of a protein on the surface of T-cells to increase the spread of T-cells within tumors and decrease tumor growth. Imjudo’s dosing for NSCLC is 75mg given once per cycle for the first four three-week cycles and then as one final dose at 16 weeks. In the decisive clinical trial, about one-quarter of patients receiving the combination treatment survived for at least three years as opposed to fewer than 14% of those using just chemo. Imfinzi has previous indications for treating adults who have other types of NSCLC, extensive-stage small cell lung cancer (ES-SCLC), or biliary tract cancer. Together, Imfinzi and Imjudo are approved to treat hepatocellular carcinoma (HCC). Full updated prescribing information is here for Imfinzi; Imjudo’s is here.

Pediatric Indication for Adcetris

Adcetris^® (brentuximab vedotin – Seagen) was FDA approved on Nov. 10, 2022, for first-line treatment of patients at least two years old who have high-risk classical Hodgkin lymphoma (cHL). An antibody-drug conjugate (ADC), Adcetris contains an anti-CD30 monoclonal antibody attached to a toxic agent that is released into CD30-expressing tumor cells, which are overproduced by cHL. A standard chemo regimen that includes doxorubicin, vincristine, etoposide, prednisone, and cyclophosphamide (AVE-PC) will be used, as well. Delivered by 30-minute IV infusions, the recommended dose is 1.8mg/kg once every three weeks for no more than five cycles. Total doses per treatment cycle should not exceed 180mg. Initially approved in the U.S. in 2011, Adcetris has additional indications for adults who have cHL, several other types of lymphoma, or mycosis fungoides (MF) that express CD30. A boxed warning cautions that, although extremely rare, using Adcetris has been associated with cases of progressive multifocal leukoencephalopathy (PML), a serious brain infection that can result in death. Here is its updated prescribing information.

FDA Approves a New Formulation of Rotarix

A more convenient form of GSK’s Rotarix^®, (rotavirus vaccine, live, oral) suspension, which is given to prevent gastroenteritis caused by rotavirus infections in infants, has been approved by the FDA. Fairly common and usually mild, but highly contagious; rotavirus causes fever, nausea and diarrhea. Most patients who are infected clear the virus after a few days, but some, especially very young children who have immunocompromising conditions, may have severe consequences that can include dehydration and metabolic acidosis. After reliable vaccines for rotavirus were introduced in the U.S. about 15 years ago, vaccinating very young babies has prevented an estimated 45,000 hospitalizations due to rotavirus every year. On Nov. 7, 2022, GSK announced that a dosing device prefilled with liquid Rotarix likely will be available early next year. Presently, the vaccine is manufactured only in single-dose vials containing a powder. Dispensed along with a delivery device that holds a liquid to dilute the powder, doses have to be mixed before oral administration. Recommended dosing is once when the child is six weeks old and once more at least four weeks — but no more than 16 weeks — later. Babies who have deformations in their gastrointestinal (GI) tracts should not be given any rotavirus vaccine, because previous versions were associated with rare cases of intussusception, potentially fatal blockages caused when one part of the GI tract slides into another part. Rotarix cannot be used to treat rotavirus, and children who have nausea and/or diarrhea from any cause should not receive the vaccine until they have recovered. Look here for full prescribing information.