FDA Updates

The US FDA approved a new indication for sacituzumab govitecan for patients with unresectable, locally advanced or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer after endocrine-based therapy and at least two additional systemic therapies for metastatic disease.

Adverse events: decreased leukocyte count, decreased neutrophil count, decreased hemoglobin, decreased lymphocyte count, diarrhea, fatigue, nausea, alopecia, glucose elevation, constipation, and decreased albumin. Labeling for the agent carries a black box warning of severe or life-threatening neutropenia and severe diarrhea.

Dose: 10 mg/kg IV on days 1 and 8 of 21-day cycles until disease progression or unacceptable toxicity.

Sacituzumab govitecan was previously approved for unresectable, locally advanced or metastatic triple-negative breast cancer after two or more prior systemic therapies and locally advanced or metastatic urothelial cancer after platinum-based chemotherapy and either a PD-1 or PD-L1 inhibitor.

Clinical Inshorts by ClinicHours

The US FDA approved pirtobrutinib (Jaypirca) for relapsed or refractory mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including a Bruton’s tyrosine kinase (BTK) inhibitor. Pirtobrutinib is the first and only non-covalent BTK inhibitor.

Dose: 200 mg once-daily

Adverse reactions: Fatigue, musculoskeletal pain, diarrhea, edema, dyspnea, pneumonia, bruising, decreased neutrophil counts, lymphocyte counts, and platelet counts.

Clinical Inshorts by ClinicHours

The US FDA has approved mosunetuzumab-axgb (Lunsumio) for use in patients with relapsed or refractory follicular lymphoma who have received at least two previous systemic therapies. This is a first-in-class bispecific antibody that is designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. Mosunetuzumab-axgb is administered as an intravenous infusion for a fixed duration, which allows for time off therapy, and can be infused in OPD.

Clinical Inshorts by ClinicHours

The US FDA has approved Adagrasib (Krazati) for use in adults with KRAS G12C-mutated locally advanced or metastatic non–small cell lung cancer (NSCLC) that has progressed on at least one prior systemic therapy.

Dose: 600mg BD

Adverse reactions: Diarrhea, nausea, fatigue, vomiting, musculoskeletal pain, hepatotoxicity, renal impairment, dyspnea, edema, decreased appetite, cough, pneumonia, dizziness, constipation, abdominal pain, and QTc interval prolongation.

Laboratory abnormalities: Decreased lymphocytes, increased aspartate aminotransferase, decreased sodium, decreased hemoglobin, increased creatinine, and decreased albumin.

Clinical Inshorts by ClinicHours

The US FDA has approved the anti-CD3 monoclonal antibody teplizumab-mzwv (Tzield, Provention Bio) to delay the onset of clinical type 1 diabetes in people aged 8 years and older who are at high risk for developing the condition. It is administered by intravenous infusion once daily for 14 consecutive days. The specific indication is to delay the onset of stage 3 type 1 diabetes in adults and pediatric patients 8 years and older who currently have stage 2 type 1 diabetes.

Type 1 diabetes staging:

• Stage 1: Presence of beta-cell autoimmunity with two or more islet autoantibodies with normoglycemia
• Stage 2: Beta-cell autoimmunity with dysglycemia yet asymptomatic
• Stage 3: Symptomatic onset of type 1 diabetes.

Stage 2 type 1 diabetes is associated with a nearly 100% lifetime risk of progression to clinical (stage 3) type 1 diabetes and a 75% risk of developing the condition within 5 years.

Clinical Inshorts by ClinicHours

The US FDA has approved a new combination of immunotherapies for use together with platinum-based chemotherapy for the treatment of adults with metastatic non–small cell lung cancer (NSCLC) whose tumors do not have EGFR mutations or ALK aberrations. The new combination comprises two drugs that act at different immune checkpoints: the CTLA-4 inhibitor tremelimumab (Imudo) and the anti-PDL1 antibody durvalumab (Imfinzi). This combination was recently approved for the first time for use in liver cancer, and durvalumab is already approved for use in lung cancer, bladder cancer, and biliary tract cancers.

Inshorts by ClinicHours

The US FDA has approved a furosemide preparation (Furoscix, scPharmaceuticals) intended for subcutaneous self-administration by outpatients with CHF and volume overload. The product is used with a SmartDose On-Body Infuser (West Pharmaceutical Services) single-use SC administration device, which affixes to the abdomen. The infuser is loaded with a prefilled cartridge and is programmed to deliver Furosemide 30 mg over 1 hour followed by a 4-hour infusion at 12.5 mg/h, for a total fixed dose of 80 mg.

Inshorts by ClinicHours

The US FDA has approved dupilumab for treating adults with prurigo nodularis, the first treatment approved for this indication.

MOA: Dupilumab (Dupixent), which inhibits the signaling of the interleukin 4 and interleukin 13 pathways, show significant improvements in both itchiness and lesion counts compared with placebo in adults with prurigo nodularis (PN).

 Dose: 300 mg SC injection every 2 weeks after a loading dose.

Adverse effects: nasopharyngitis, conjunctivitis, herpes infection, muscle pain, diarrhea

Inshorts by Clinichours

The US FDA has approved terlipressin (Terlivaz), the first and only drug approved for patients with hepatorenal syndrome (HRS). HRS is characterized by a progressive deterioration in kidney function in people with advanced liver disease. Terlipressin is an injectable synthetic vasopressin analogue indicated for patients with HRS who are experiencing rapid deterioration of kidney function (type 1 HRS).

The most commonly observed adverse reactions that occurred in at least 4% of patients treated with terlipressin were abdominal pain (19.5%), nausea (16%), respiratory failure (15.5%), diarrhea (13%), and dyspnea (12.5%).