Expanded Prostate Cancer Indication for Pluvicto

On March 28, 2025, the US Food and Drug Administration (FDA) approved Pluvicto^® (lutetium Lu 177 vipivotide tetraxetan – Novartis) to include adult patients with prostate-specific membrane antigen (PSMA)–positive metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor (AR) pathway inhibitor therapy and are considered appropriate to delay taxane-based chemotherapy. This means adults can now receive it before taxane-based chemotherapy, which is estimated to triple the population for this therapy. The phase III study supporting this approval demonstrated a statistically significant progression-free survival (PFS) of 9.3 months compared to 5.6 months for those who switched to a different AR pathway inhibitor rather than to Pluvicto. However, no significant difference was observed in overall survival for the radioligand therapy. Novartis is expanding its manufacturing capacity and Pluvicto will continue to be available through designated treatment centers. Here is the updated prescribing information.

New Bladder Cancer Indication for Imfinzi

AstraZeneca’s Imfinzi^® (durvalumab) was approved on March 31, 2025, in combination with gemcitabine and cisplatin for the treatment of muscle-invasive bladder cancer (MIBC). The American Cancer Society (ACS) estimates that about 83,000 new cases of bladder cancer are discovered in the US each year, with roughly eight out of ten being MIBC. The current standard of care is neoadjuvant chemotherapy and removal of the bladder; however, even after removal, disease recurrence is common. This approval marks the first programmed death-ligand 1 (PD-L1) blocking immunotherapy with survival data for MIBC. Studies showed that the Imfinzi-based perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy (p=0.0106). This prompted Imfinzi addition to the National Comprehensive Cancer Network (NCCN) Guidelines as a Category 1 recommended regimen for patients with MIBC. For bladder cancer, Imfinzi will be administered by intravenous (IV) infusion at a dosage of 1,500mg every three weeks in combination with gemcitabine and cisplatin for four cycles prior to surgery as neoadjuvant therapy and 1,500mg every four weeks as a single agent for up to eight cycles after surgery for patients weighing 30kg or more. For patients weighing less than 30kg, the dosage will be 20mg/kg. Imfinzi has previous indications for treating adults who have other multiple types of non-small cell lung cancer (NSCLC), extensive-stage small cell lung cancer (SCLC) or biliary tract cancer. Together, Imfinzi and Imjudo^®(tremelimumab-actl) injections are approved to treat unresectable hepatocellular carcinoma (HCC) and NSCLC without EGFR, ALK or ROS1 mutations. They are used along with chemo that includes a platinum-containing drug. It is also used to treat adults with primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR). Prescribing information is here.

New Formulation of Jynneos

On March 31, 2025, the FDA approved a freeze-dried formulation of Jynneos^® (smallpox and mpox vaccine, live, non-replicating – Bavarian Nordic) for the prevention of smallpox and mpox disease. Jynneos has been a liquid-frozen formulation with specific cold requirements so this new freeze-dried formulation can simplify transportation and storage conditions. This is important in case of an outbreak and provides flexibility in stockpiling. Updated prescribing information is here.

Vanrafia Approved for IgA Nephropathy

The FDA granted accelerated approval to Vanrafia^® (atrasentan – Novartis) for the reduction of proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression on April 2, 2025. IgAN is an autoimmune kidney disease that affects approximately 130,000 Americans. It slowly causes kidney damage and up to 50% of patients will develop kidney failure within 20 years of diagnosis often requiring dialysis or kidney transplant. Accelerated approval is based on interim results from an ongoing phase III study that showed significant proteinuria reduction of 36.1% compared to placebo with results seen as early as week six and sustained until month nine.  Final study results to determine if Vanrafia slows kidney function decline is required before the FDA will consider granting full approval for this expanded indication. Complete data from this study are expected to be available 2026. A first in class endothelin A receptor antagonist, Vanrafia is taken orally once daily at a dose of 0.75mg and can be added on to renin-angiotensin system (RAS) inhibitor with or without a sodium-glucose co-transporter-2 (SGLT2) inhibitor. The cost and launch date are not yet known. Full prescribing information can be found here.

Uplizna Gets New Indication for IGG4-Related Disease

On April 3, 2025, the FDA approved Uplizna^® (inebilizumab-cdon – Amgen) for adults living with Immunoglobulin G4-related disease (IgG4)-RD. This is the first treatment for the chronic, immune-mediated inflammatory condition that affects any organ system with periods of disease flares. The phase III trial showed an 87% reduction in risk of flare compared to placebo. The most common adverse effects were urinary tract infection and lymphopenia. A CD19-directed cytolytic antibody, Uplizna was originally approved for treating neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive. A myasthenia gravis indication is anticipated in 2026. The recommended dose is two 300mg intravenous (IV) infusions two weeks apart, followed by one dose every six months. Here is the prescribing information.

Recall

Gamunex-C 40G Vials Recalled On March 21, 2025, Grifols Therapeutics LLC withdrew one additional lot of Gamunex-C^® (immune globulin injection [human], 10% caprylate/chromatography purified) 40G vials to the consumer level due to an increased rate of reported hypersensitivity reactions with the affected lot. Previously, Grifols had withdrawn one lot on Feb. 20, 2025, for the same reason. Gamunex-C is an immune globulin solution indicated for treating primary humoral immunodeficiency (PI) in patients two years of age or older, idiopathic thrombocytopenic purpura (ITP) in adults and children and chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Hypersensitivity and anaphylactic reactions are listed in the warnings and precautions section for the prescribing information; however, this lot may pose a higher risk for these reactions. To read more about the recall, see here.