Oncology

Other news includes the launches of the first generic of an ulcer drug, the antipsychotic lurasidone, an extended-release version of topiramate for migraine, and additional strengths of the cancer drug lenalidomide. Additionally, Glenmark will distribute Cediprof's generic Adderall, and the FDA has accepted Amneal’s application for a generic naloxone nasal spray.

Niraparib and abiraterone acetate plus prednisone has potential to address unmet need for patients with BRCA-positive metastatic castration-resistant prostate cancer.

BMS is seeking an indication for Opdivo as monotherapy to treat patients with stage IIB or IIC melanoma after surgery. The FDA has assigned a Prescription Drug User Fee Act date of Oct. 13, 2023.

Patients who have had liver problems in the past may be at risk of liver damage from Sprycel, which is used to treat patients with chronic myeloid leukemia.

Phase 3 data showed that the combination resulted in a 37% reduction in risk of disease progression or death in men with advanced prostate cancer.

Conversion from accelerated to regular approval was based on long-term outcomes from a phase 1 trial, which demonstrated an overall response rate of 45.4%.

Gastroesophageal reflux disease is a risk factor for what is now the more common type of esophageal cancer, adenocarcinoma. Immunotherapy is coming on strong as a treatment.

Trodelvy has been recommended as a preferred treatment for metastatic HR+/HER2- breast cancer by the National Comprehensive Cancer Network.

Dosing has been lowered to reduce the risk of liver damage in patients taking Turalio, which is approved to treat patients with a rare tumor that affects the joints.

The collaboration between Cost Plus Drugs and OncoPower provides access to generic medications for patients with cancer integrated with OncoPower’s Pill Reminder tool.

Elacestrant, now with the brand name Orserdu, is an oral selective estrogen receptor degrader (SERD), which works by blocking the effects of estrogen on hormone receptor-positive breast cancer cells.

Jaypirca is the first BTK inhibitor specifically approved for patients with mantle cell lymphoma previously treated with a covalent BTK inhibitor. It has a wholesale acquisition cost of $21,000 per 30 days of therapy.

This approval marks the fifth indication for Keytruda-based regimens in non-small cell lung cancer and the 34th indication in the United States.

This is the fourth indication for the Bruton’s tyrosine kinase inhibitor.

Tukysa with trastuzumab is indicated for second-line treatment of HER2-positive metastatic colorectal cancer, the first such therapy for this cancer.

Newer treatments, including targeted and immunotherapies, have contributed to an increase in five-year survival rates for patients with some cancers.

Genentech’s glofitamab is a bispecific antibody being reviewed to treat adults with large B-cell lymphoma. The FDA is expected to make a decision on approval by July 1, 2023.

Synergie Medication Collective, which launches this month, is focused on improving affordability and access to gene therapies, infusible cancer drugs and other medications administered in a clinical setting.

This year's most-read cancer news included researchers finding a possible liver cancer immunotherapy, cancer patients facing many negative impacts from COVID-19 and more.

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.