PDR Drug Update - October 2026

Expanding Treatment Options for Dermatomyositis

Dermatomyositis is a rare autoimmune inflammatory disease that primarily affects the skin and skeletal muscles, although other organs can also be involved. Dermatomyositis can cause progressive, symmetric muscle weakness, particularly in the muscles around the shoulders, hips, and thighs. Characteristic skin findings include Gottron papules, which are dark red or purple raised lesions that tend to appear over the knuckles, elbows, and knees, and a heliotrope rash, a purple discoloration around the eyelids. Patients sometimes also develop interstitial lung disease and other systemic complications that may be fatal.

Treatment of dermatomyositis generally relies on corticosteroids along with other immunomodulatory or immunosuppressive therapies. Prednisone and other glucocorticoids are commonly used in initial treatment, while methotrexate, azathioprine, and mycophenolate mofetil may be used as steroid-sparing treatments. Calcineurin inhibitors, hydroxychloroquine, intravenous immune globulin, and rituximab are also used in certain patients, particularly when disease is severe or does not respond adequately to initial therapy. Treatment paths may differ according to whether muscle, skin, lung, or other manifestations are most prominent.

Lisraya (brepocitinib) recently received FDA approval for adults with dermatomyositis and is the first approved oral treatment specifically indicated for the condition. A benefit of brepocitinib is that it targets multiple inflammatory pathways to address the disease's biological drivers. Brepocitinib is an oral Janus kinase (JAK) and tyrosine kinase 2 (TYK2) inhibitor that selectively inhibits JAK1 and TYK2, which are proteins involved in signaling by several cytokines that contribute to inflammation. The recommended dosage of brepocitinib is a 30mg tablet taken once daily.

Approval was supported by the phase 3 VALOR trial, which included 210 adults with dermatomyositis who received brepocitinib or placebo once daily for 52 weeks while continuing permitted standard background therapies. At week 52, 68% of patients receiving brepocitinib 30mg achieved moderate clinical improvement, while 46% of patients achieved major clinical improvement. This was compared to patients receiving placebo, who showed 44% and 26% improvement, respectively. Analysis of skin outcomes also found that brepocitinib 30mg improved cutaneous disease activity compared with placebo as early as week 4, with benefits maintained through week 52.

Brepocitinib carries a boxed warning for serious infections, mortality, malignancies, major adverse cardiovascular events, and thrombosis. Serious infections were reported more frequently with the 30mg dose than with placebo in the VALOR trial, occurring in 10% and 1% of patients, respectively. The most common adverse reactions occurring in at least 5% of patients treated with brepocitinib were upper respiratory tract infection, headache, fatigue, urinary tract infection, nausea, bronchitis, arthralgia, diarrhea, back pain, falls, influenza, and acne. Patients should be evaluated for tuberculosis and viral hepatitis before treatment and monitored during therapy for laboratory abnormalities and serious infections. Brepocitinib is also not recommended for use with other JAK inhibitors, other TYK2 inhibitors, or biologic disease-modifying antirheumatic drugs due to potential serious side effects.

Dermatomyositis is a complex disease that can greatly impair patients' quality of life. As the first oral therapy approved by the FDA for treatment of dermatomyositis, brepocitinib offers an additional option for patients and medical providers. Patients with dermatomyositis often require long-term treatment and may continue to experience disease activity despite therapy. The availability of a targeted treatment developed specifically for dermatomyositis represents an important advance in managing this rare disease. Stay informed about emergent drug information, including further dermatomyositis-related approvals, by exploring PDR by ConnectiveRx. You can also stay current by using the official PDR app, mobilePDR, which is available for free from your preferred app store.

FDA New Approvals

Bexlutry

The FDA has approved Bexlutry (lutetium Lu177 dotatate) for the treatment of adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors, including foregut, midgut, and hindgut neuroendocrine tumors. Learn more about Bexlutry

Bixlenvo

The FDA has approved Bixlenvo (bictegravir/lenacapavir), an integrase strand transfer inhibitor and capsid inhibitor combination for the treatment of HIV-1 infection in adults who are virologically suppressed. Learn more about Bixlenvo

Etcamah

The FDA has approved Etcamah (camizestrant) in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (abemaciclib, palbociclib, or ribociclib) for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative, locally advanced or metastatic breast cancer upon detection of ESR1 mutation during aromatase inhibitor and CDK4/6 inhibitor therapy, based on an FDA-authorized test. Learn more about Etcamah

Fayuvi

The FDA has approved Fayuvi (rebisufligene etisparvovec-hopf) for the treatment of pediatric patients with mucopolysaccharidosis type IIIA (Sanfilippo syndrome Type A). Learn more about Fayuvi

Isembyld

The FDA has approved Isembyld (apitegromab-mstn) for the treatment of spinal muscular atrophy in adults and children 2 years of age and older who are currently receiving a survival motor neuron 2-targeted treatment. Learn more about Isembyld

Lisraya

The FDA has approved Lisraya (brepocitinib) for the treatment of adults with dermatomyositis. Learn more about Lisraya

Mimrylo

The FDA has approved Mimrylo (rusfertide) for the treatment of erythrocytosis in adults with polycythemia vera, a blood cancer. Learn more about Mimrylo

Omcazio

The FDA has approved Omcazio (cabozantinib) for use in the treatment of renal cell carcinoma, hepatocellular carcinoma, and extra-pancreatic neuroendocrine tumors. Learn more about Omcazio

Pixclara

The FDA has approved Pixclara (floretyrosine F 18), an amino acid positron emission tomography drug for imaging gliomas. Pixclara is a radioactive diagnostic drug indicated for use with positron emission tomography to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and pediatric patients aged 1 month and older. Learn more about Pixclara

Rasonque

The FDA has approved Rasonque (daraxonrasib) for the treatment of adult patients with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy or who are not candidates for multiagent systemic therapy. Learn more about Rasonque

Zanvastro

The FDA has approved Zanvastro (zilganersen) for the treatment of Alexander disease in pediatric and adult patients. Learn more about Zanvastro

FDA New Indications

Ameluz

The FDA has approved Ameluz (aminolevulinic acid HCl) topical gel, 10%, in combination with photodynamic therapy using the BF-RhodoLED lamp series, for the treatment of superficial basal cell carcinoma in adults. Learn more about Ameluz

Besremi

The FDA has approved Besremi (ropeginterferon alfa-2b-njft) for the treatment of adults with essential thrombocythemia (ET), making it the first new FDA-approved treatment for ET in nearly three decades. Learn more about Besremi

Hyrnuo

The FDA has approved Hyrnuo (sevabertinib) for the first-line treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have human epidermal growth factor receptor 2 tyrosine kinase domain activating mutations, as detected by an FDA-authorized test. Learn more about Hyrnuo

Imaavy

The FDA has approved Imaavy (nipocalimab-aahu) for the treatment of warm autoimmune hemolytic anemia in adult and pediatric patients aged 12 years and older currently or previously treated with corticosteroids. Learn more about Imaavy

Joenja

The FDA has approved Joenja (leniolisib), an oral, selective phosphoinositide 3-kinase delta inhibitor, as a treatment for children aged 4 to 11 years weighing at least 27kg with activated phosphoinositide 3-kinase delta syndrome, a rare primary immunodeficiency. Learn more about Joenja

Kerendia

The FDA has approved Kerendia (finerenone) to reduce urinary albumin-to-creatinine ratio, which is expected to reduce the risk of sustained estimated glomerular filtration rate decline and end-stage kidney disease in adults with chronic kidney disease associated with type 1 diabetes. Learn more about Kerendia

Mounjaro

The FDA has approved Mounjaro (tirzepatide), a dual GIP and GLP-1 hormone receptor agonist, to lower the risk of major adverse cardiovascular (CV) events, including CV death, non-fatal heart attack, or non-fatal stroke in adults with type 2 diabetes who are at high risk for these events. Mounjaro is already approved as an adjunct to diet and exercise to improve blood sugar in adults and children aged 10 years and older with type 2 diabetes. Learn more about Mounjaro

Stelara

The FDA has approved Stelara (ustekinumab) injection for the treatment of moderately to severely active ulcerative colitis in pediatric patients aged 2 years and older. Learn more about Stelara

Tivicay PD

The FDA has approved Tivicay PD (dolutegravir) for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients (treatment-naïve or -experienced but integrase strand transfer inhibitor-naïve) weighing at least 2kg. Learn more about Tivicay PD

FDA New Combinations

Inluriyo + Verzenio

The FDA has approved Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with estrogen receptor-positive, human epidermal growth factor receptor 2-negative, estrogen receptor 1-mutated advanced or metastatic breast cancer, as detected by an FDA-authorized test, with disease progression following at least one line of endocrine therapy. Learn more about Inluriyo + Verzenio

Ziihera-Containing Regimens

The FDA has approved two Ziihera (zanidatamab-hrii)-containing regimens for the first-line treatment of adults with unresectable locally advanced or metastatic HER2-positive (HER2+) gastroesophageal adenocarcinoma (GEA): Ziihera plus Tevimbra (tislelizumab-jsgr) and fluoropyrimidine- and platinum-containing chemotherapy (HER2+ IHC 3+ and IHC 2+/ISH+), and Ziihera plus fluoropyrimidine- and platinum-containing chemotherapy (HER2+ IHC 3+). Learn more about Ziihera-containing regimens

FDA Labeling Changes

Imdelltra

The FDA has approved an update to the Imdelltra (tarlatamab-dlle) that reduces the recommended monitoring time for the first two doses of treatment in an appropriate healthcare setting. Patients should now be monitored for 6 to 8 hours from the start of their first two infusions, compared with the previously recommended 22 to 24 hours. Patients will also receive a follow-up assessment, including vital signs, the day after each of these first two doses. Learn more about Imdelltra

FDA New Formulations

Comirnaty

The FDA has approved the Comirnaty (COVID-19 vaccine, mRNA) 2026-2027 vaccine formula targeting the XFG variant for use in adults aged 65 years and older, as well as in individuals aged 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19. Learn more about Comirnaty

Mnexspike

The FDA has approved an updated formula for Mnexspike (COVID-19 vaccine, mRNA) for individuals aged 12 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults aged 65 years and older. Learn more about Mnexspike

Nuvaxovid

The FDA has approved an updated formula for Nuvaxovid (COVID-19 vaccine, adjuvanted) to target the SARS-CoV-2 XFG variant for the 2026-2027 vaccination season in individuals aged 12 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19, and all adults aged 65 years and older. Learn more about Nuvaxovid

Spikevax

The FDA has approved an updated formula for Spikevax (COVID-19 vaccine, mRNA) for individuals aged 6 months through 64 years with at least one underlying condition placing them at high risk for severe outcomes from COVID-19, and all adults aged 65 years and older. Learn more about Spikevax

FDA Recalls

A&P Creations Biq-fel

A&P Creations is recalling certain lots of dietary supplement Biq-fel 500mL, at the consumer level, because it has been found to contain undeclared sildenafil and tadalafil. Learn more about the Biq-fel recall

A&P Creations X10

A&P Creations is recalling X10 natural enhancement supplement to the consumer level because it has been found to contain undeclared sildenafil and tadalafil. Learn more about the X10 recall

American Regent Epinephrine

American Regent, Inc. is conducting a nationwide voluntary recall of three lots of epinephrine injection, USP 30mg/30mL (1mg/mL) multi-dose vials, to the consumer level. Customer complaints were received for leaking and cracked vials, resulting in a lack of assurance of sterility. The firm’s investigation also revealed the presence of particulate matter identified as nylon, cellulosic, acrylic, polyethylene and glass. Learn more about the epinephrine recall

Ana Salazar Modela Tu Cuerpo Lipofit

Ana Salazar Modela Tu Cuerpo Inc. is recalling Lipofit Extreme Fat Burner 2.0, Lot 25M12F, expiration date 09/2027, to the consumer level. FDA laboratory analysis has found the product to be tainted with undeclared fluoxetine in the daytime tablets and undeclared 2,4-dinitrophenol in the nighttime tablets. Learn more about the Lipofit recall

B. Braun Sodium Chloride

Braun Medical Inc. is voluntarily recalling 3 lots of 0.9% sodium chloride injection USP, 100mL, in a 150mL PAB container, to the hospital/healthcare facility/user level, due to presence of particulate matter identified as iron oxide, inorganic, cellulose, or polystyrene particulate matter. Learn more about the sodium chloride recall

Baxter Anticoagulant Sodium Citrate

Baxter International Inc. is voluntarily recalling one lot (lot: Y493475, expiration date: 31-Dec-2027, NDC: 0338-9669-01) of anticoagulant sodium citrate solution due to the potential presence of particulate matter identified as fiberglass in the solution. Learn more about the anticoagulant sodium citrate recall

Baxter Dextrose

Baxter International Inc. is voluntarily recalling one lot of 70% dextrose injection (lot: Y495066, expiration date: 31-Jul-2027, NDC 0338-0719-06) due to the potential presence of particulate matter identified as stainless steel particles in the solution. Learn more about the dextrose recall

Baxter Sodium Chloride

Baxter International Inc. is voluntarily recalling two lots of 0.9% sodium chloride injection (lots: Y495523, Y495523A; expiration date: 31-Oct-2027, NDC 0338-0049-03) due to the potential presence of particulate matter identified as fiberglass in the solution. Learn more about the sodium chloride recall

Centric Compounding Products

Centric Compounding is voluntarily recalling 6 lots of glutathione 200mg/mL, Myer’s Cocktail, and Tri-Immune Boost injectable vials, to the consumer level. The products have been found to be compounded with a glutathione API containing elevated endotoxin levels. Learn more about the Centric Compounding products recall

Supplx.com Dietary Supplements

Supplx.com is voluntarily recalling Business Pill and Branch Manager for Men, products marketed as dietary supplements for male sexual enhancement, because FDA laboratory analysis confirmed that both products contain yohimbine that is not declared on the product labels. Learn more about the Supplx.com dietary supplements recall

Vitruvias Thyroid Tablets

Vitruvias Therapeutics Inc. is voluntarily recalling one lot of thyroid tablets, USP 30mg (lot: 504950), to the consumer level. The product is being recalled because testing confirmed the potential for the product to be superpotent. Learn more about the thyroid tablets recall

FDA Drug Safety Communications

Injectafer

The FDA has approved revisions to the labeling for Injectafer (ferric carboxymaltose) injection that add a boxed warning, the agency’s most prominent safety warning. This boxed warning describes the risk for symptomatic hypophosphatemia associated with ferric carboxymaltose injection and recommends phosphate monitoring in patients at risk of hypophosphatemia and in any patient who receives a repeat course of therapy within three months of the prior course. Learn more about the Injectafer labeling changes

Kybella

The FDA has approved an additional warning in labeling for Kybella (deoxycholic acid) injection regarding adverse reactions associated with use of the drug outside of the submental fat region (fat under the chin, known as a “double chin”) and recommends against this unapproved use. Learn more about the Kybella labeling changes

October 2026