Oncology

Lunsumio is Genentech’s first approved T-cell engaging bispecific antibody and targets CD20 on the surface of B cells and CD3 on the surface of T cells.

The combination includes an antibody-drug conjugate with an immunotherapy to treat patients with advanced bladder cancer. The PDUFA action date is April 21, 2023.

Rezlidhia is an oral, small molecule inhibitor of mutated IDH1 that was approved by the FDA to treat patients with relapsed or refractory acute myeloid leukemia.

Researchers modeling the cost-effectiveness of chimeric antigen receptor T-cell therapy (CAR-T) therapy and antibody conjugate found that they fell short.

Cytalux, approved in November 2021 for identifying ovarian cancer lesions, is now approved to spot lung cancer during surgery.

Adstiladrin offers an alternative to bladder removal surgery for patients who are at high risk of recurrence and metastatic cancer.

HyBryte is a photodynamic therapy. The active ingredient, synthetic hypericin, is topically applied to skin lesions that is taken up by the malignant T-cells and activated by visible light.

The agency has extended the review time by three months for Lynparza in combination with abiraterone and prednisone or prednisolone.

Moderna is developing an individualized cancer vaccine that uses mRNA technology to specifically target that person’s cancer.

Magellan Rx predicts oncology and high-cost rare disease treatments will continue to drive medical pharmacy spend in commercial, Medicaid and Medicare.

The FDA issued an accelerated approval for Mirati’s Krazati for patients with KRAS-mutated non-small cell lung cancer. The agency also approved a companion diagnostic to identify eligible patients.

Talquetamab is a bispecific antibody that targets both CD3 on T cells and GPRC5D, which is overexpressed on myeloma cells.

Oncopeptides disagrees with the FDA about Pepaxto and will make a decision about next steps by the end of the first quarter of 2023.

The researchers have several suggestions for how harm from screening should be reported in screening guidelines.

In October, an FDA advisory committee voted against omburtamab, saying the trials didn’t show evidence that the therapy improves overall survival.

I/Ontak is an engineered IL-2-diphtheria toxin fusion protein. The PDUFA target action date is Sept. 28, 2023.

Doctors surveyed by the Association for Clinical Oncology said payer prior authorization can cause disease progression and loss of life.

A confirmatory trial of Tecentriq in urothelial carcinoma failed to meet the co-primary endpoint of overall survival.

An advisory committee had voted against poziotinib to treat patients with non-small cell lung cancer with HER2 exon 20 insertion mutations.

A confirmatory trial in patients with relapsed or refractory multiple myeloma did not meet its primary endpoint of progression-free survival.

If approved, epcoritamab would be the first bispecific antibody to treat adult patients with relapsed/refractory large B-cell lymphoma. The Prescription Drug User Fee Act date is May 21, 2023.

Rylaze’s dosing options provide sustained asparaginase activity throughout the entire course of treatment for adult and pediatric patients with acute lymphoblastic leukemia or lymphoblastic lymphoma.

After review of phase 3 data, GSK will limit the use of Zejula in the second line to those with inherited BRCA mutations.

Elahere is a first-in-class antibody-drug conjugate targeted against folate receptor alpha, a protein on the surface of ovarian cancer cells.

Positive results for Adcetris (brentuximab vedotin) were reported in The New England Journal of Medicine. Further research will include a look at the cost effectiveness of Adcetris.

Imjudo is a monoclonal antibody that targets the activity CTLA-4 that was approved to be used in combination with Imfinzi, a PD-L1 inhibitor, for patients with non-small cell lung cancer.

IPX203 is an oral formulation of carbidopa/levodopa extended-release capsules that, if approved, could provide patients with better symptom control. The FDA assigned a Prescription Drug User Fee Act date of June 30, 2023.

In a trial of patients two years and older, Adcetris plus standard of care chemotherapy led to a 59% reduction in risk of disease progression or relapse, second malignancy or death

If approved, Aphexdra would be used along with G-CSF treatment for autologous transplantation in patients with multiple myeloma. The Prescription Drug User Fee Act target action date is Sept. 9, 2023.

The new indication expands the patient population eligible for a Libtayo-based regimen to include combination treatment with chemotherapy irrespective of PD-L1 expression levels.