SPOTLIGHT -
Genentech Withdraws Tecentriq Indication for Bladder Cancer
A confirmatory trial of Tecentriq in urothelial carcinoma failed to meet the co-primary endpoint of overall survival.
FDA Issues CRL for Poziotinib for Lung Cancer
An advisory committee had voted against poziotinib to treat patients with non-small cell lung cancer with HER2 exon 20 insertion mutations.
GSK Pulls Blenrep from U.S. Market
A confirmatory trial in patients with relapsed or refractory multiple myeloma did not meet its primary endpoint of progression-free survival.
FDA Accepts for Priority Review BLA for Epcoritamab
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.
FDA Approves Alternate Dosing Schedule for Rylaze
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.
GSK Limits Use of Zejula for Some Cancer Patients
After review of phase 3 data, GSK will limit the use of Zejula in the second line to those with inherited BRCA mutations.
FDA Grants Accelerated Approval of Novel Ovarian Cancer Therapy
Elahere is a first-in-class antibody-drug conjugate targeted against folate receptor alpha, a protein on the surface of ovarian cancer cells.
FDA Clears Imfinzi/Imjudo Combination for Lung Cancer
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.
FDA Accepts NDA for Novel Parkinson’s Disease Therapy
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.
FDA Approves Adcetris for Younger Patients with Hodgkin Lymphoma
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
FDA Accepts NDA of Aphexda for Use in Stem Cell Mobilization
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.
FDA Approves Libtayo for Second Indication in Advanced Lung Cancer
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.
Real-world Data Show Gardasil Protects Against Cervical, Non-Cervical Diseases
The greatest reductions were seen in girls who were vaccinated when they were adolescents, with up to 73% reduction in cervical pre-cancerous lesions.
FDA Approves Melanoma Drug to Treat Blood Cancers
Cotellic, an oral inhibitor of MEK1 and MEK2, was approved to treat patients with histiocytic neoplasms based on a phase 2 trial conducted solely at Memorial Sloan Kettering Cancer Center.
Genmab Submits Applications for Bispecific Therapy for Large B-cell Lymphoma
Epcoritamab is designed to simultaneously bind to CD3 on T cells and CD20 on B-cells
Updated: FDA Approves First Bispecific Antibody for Multiple Myeloma
Tecvayli targets BCMA and CD3 to activate the body’s immune system. It was approved for heavily pretreated patients with relapsed or refractory multiple myeloma.
FDA Grants Priority Review for Acute Myeloid Leukemia Drug
Quizartinib, which is under review to treat adult patients with newly diagnosed acute myeloid leukemia who are FLT3-ITD positive, has a Prescription Drug User Fee Act date (PDUFA) of April 24, 2023.
FDA Clears Novel Liver Cancer Combo Treatment
Regulators have approved Imjudo, a monoclonal antibody that targets the activity CTLA-4, to be used in combination with Imfinzi, a PD-L1 inhibitor.
Up, Up and Not Going Away: Cancer Drug Prices
Escalating costs are hitting patients hard. CMS price negotiation and the $2,000 cap on Part D out-of-pocket expenses should benefit many patients with Medicare coverage.
FDA Approves Therapy for Bile Duct Cancer
Taiho’s Lytgobi is approved to treat advanced or metastatic advanced bile duct cancer in patients with FGFR2 gene fusions.
IQVIA: Payers Increase Exclusions for Oncology Drugs
Jing Yang from IQVIA discusses how national payers are using formulary exclusions for oncology therapeutics.
FDA Approves Fourth Avastin Biosimilar
Vegzelma is Celltrion’s third oncology biosimilar to be approved by the FDA.
FDA Advisory Committee Votes Against Copiktra in CLL/SLL
Committee members felt the data on overall survival for patients treated with Copiktra was difficult to interpret, and the therapy was associated with a higher risk of serious side effects and deaths compared with Kesimpta.
FDA Advisory Committee Votes Down Pepaxto for Multiple Myeloma
While some patients with relapsed or refractory multiple myeloma saw a benefit in a confirmatory trial, the main issue concerning the committee members was a high rate of death in the study.
FDA Advisory Committee Votes Against Poziotinib for NSCLC
Several concerns factored into the decision, including a low overall response rate and high rate of adverse events, a dose that was not optimized and a confirmatory trial that will not likely see results until 2026.
FDA Grants Accelerated Approval of Retevmo for Tumor Agnostic RET Gene Fusions
This is the first RET Inhibitor for adults with advanced or metastatic solid tumors with a RET gene fusion, regardless of tumor type.
FDA Accepts sNDA for Tukysa for HER2 Positive Colorectal Cancer
There are currently no FDA-approved therapies that specifically target HER2 in colorectal cancer. The agency has set a target action date of Jan. 19, 2023.
Servier Selects Onco360 as Pharmacy Partner for Tibsovo
Approved in May 2022, Tibsovo is the first therapy targeting cancer metabolism for older patients with newly diagnosed IDH1-mutated acute myeloid leukemia.
Clovis Submits Supplemental Applications for Rubraca for Advanced Ovarian Cancer
The applications are based on progression-free survival data even though the FDA has recommended that the company wait for more mature overall survival data.
Texas Ruling on HIV PrEP Could Impact Other Preventive Coverage
A Texas judge ruled that coverage for HIV pre-exposure prophylaxis (PrEP) violates religious freedom but there is concern that cancer screenings and other preventive services could be affected.