December 4th 2023
Shortages are growing because of disruption caused natural disasters and ingredient supply issues, as well as increased demand for certain drugs.
Jaypirca is also approved to treat mantle cell lymphoma. It has a list price of $21,000 for a 30-day supply.
November 28th 2023
Ogsiveo will be available within five to 10 business days to treat patients with desmoid tumors. It will launch with a price of $29,000 for a 30-day supply.
November 21st 2023
Janssen is seeking approval for use after Tagrisso in patients with metastatic non-small cell lung cancer.
A regulatory decision will not be made by the Prescription Drug User Fee Act (PDUFA) target action date of Dec. 16, 2023.
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.
FDA Approves Rolvedon to Prevent Chemotherapy-related Infections
Rolvedon, which previously had the brand name Rolontis, is the first novel long-acting GCSF product approved in more than 20 years. Spectrum Pharmaceuticals expects it to be available in the fourth quarter.
Dr. Reddy’s Launches, Cipla Receives Approval for Generic Revlimid
Dr. Reddy’s received a first-to-market 180 days of exclusivity for the 2.5 mg and 20 mg strengths of its generic lenalidomide capsules.
Prime Develops Predictive Model to Identify Savings in Breast Cancer
Prime Therapeutics’ predictive model was able to identify members with high breast cancer pharmacy and medical claims to help clients better manage drug spend.
FDA Approves Stimufend, a Biosimilar to Neulasta
Fresenius Kabi expects to launch Stimufend as a prefilled syringe early in 2023.
FDA Approves Imfinzi for Metastatic Biliary Tract Cancer
A phase 3 trial showed that Imfinzi in combination with chemotherapy reduced the risk of death by 20% compared with chemotherapy alone.
FDA Approves First Targeted Treatment for Myeloid/Lymphoid Neoplasms
Pemazyre is the first approved treatment specifically for patients with FGFR1 rearrangement, a rare blood cancer.
FDA Expands Imbruvica for Young Children with GVHD
Imbruvica is the first approved treatment option for children under 12 with chronic graft versus host disease and the first BTKi therapy approved for pediatric patients.
FDA Accepts NDA for GSK’s Myelofibrosis Drug
The FDA has assigned a Prescription Drug User Fee Act action date of June 16, 2023.
Sanofi Stops Development of Amcenestrant
After a failed trial in advanced breast cancer, Sanofi has stopped all studies of amcenestrant, including in early-stage breast cancer.
FDA Grants Priority Review to Lynparza/Abiraterone for Metastatic Prostate Cancer
The FDA has set a Prescription Drug User Fee Act date in the fourth quarter of 2022.
FDA Accepts Polivy sBLA for Aggressive Blood Cancer
The FDA is expected to make a decision on approval of the combination of Polivy with Rituxan and the R-CHP regimen by April 2, 2023.
FDA Approves Enhertu for Metastatic Lung Cancer
Enhertu is the first HER2 directed drug to be approved for the treatment of patients with HER2 mutated metastatic non-small cell lung cancer.
FDA Assigns Priority Review for Elacestrant in Metastatic Breast Cancer
If approved, elacestrant would be the first oral selective estrogen receptor degrader (SERD) as a second- or third-line treatment for patients with ER+/HER2- advanced or metastatic breast cancer. The PDUFA date is Feb. 17, 2023.
CivicaScript Launches Generic Abiraterone
Abiraterone is used together with prednisone to treat patients with metastatic prostate cancer.
FDA Approves Additional Indication for Nubeqa
Nubeqa, in combination with docetaxel, is now approved to treat metastatic prostate cancer.
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