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.
November 20th 2023
Truqap is an AKT kinase inhibitor that, along with Faslodex, reduced the risk of disease progression or death by 50%.
Contamination with Penicillium brevicompactum could lead to invasive fungal infections of the blood or pneumonia that can be life-threatening in immunocompromised patients.
FDA Approves Jakafi for GVHD
This is the fourth approval for Jakafi, a JAK1/JAK2 inhibitor.
Merck Shares Significant Keytruda Breast Cancer Results
Keytruda plus chemotherapy reduces the risk of death by 27% in patients with triple-negative breast cancer.
FDA Approves Tivdak for Advanced Cervical Cancer
Tivdak is the first approved antibody-drug conjugate for the treatment of adult patients with recurrent or metastatic cervical cancer.
FDA Accepts BMS Application for Opdivo/Relatimab Combination for Advanced Melanoma
The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 19, 2022.
FDA Approves Cabometryx for Thyroid Cancer
The approval comes more than two months ahead of its PDUFA target date of December 4, 2021.
FDA Approves Exkivity, a Novel Oral Therapy for Lung Cancer
Takeda Oncology’s Exkivity treats non-small lung cancer in patients with EGFR exon 20 insertion mutations. This is the second approval for this mutation and the first oral therapy.
Study: Erleada Demonstrates PSA Response and Increased Patient Adherence in Prostate Cancer
Real-world data show Erleada prolonged survival in both metastatic and non-metastatic castration-sensitive prostate cancer.
Keytruda Receives Full Approval as First-Line Treatment in Bladder Cancer
The approval follows the FDA’s Oncologic Drugs Advisory Committee voting 5-3 in favor of maintaining the approval despite a confirmatory trial that found Keytruda did not meet the end points of overall survival and progression-free survival.
Genentech Withdraws Tecentriq Approval for Metastatic Breast Cancer
Tecentriq did not meet the primary end point in a postmarketing study as a first-line treatment.
FDA Approves Tibsovo for Rare, Aggressive Cancer
Tibsovo is the first targeted therapy for IDH1-mutated cholangiocarcinoma, a cancer of the bile ducts within and outside the liver.
BMS Seeks Approval of Orencia for Graft Versus Host Disease
The FDA has set a PDUFA date of December 23, 2021.
Onco360 Chosen as Specialty Pharmacy for Welireg
The therapy is the first approved for patients with tumors associated with von Hippel-Lindau disease.
Merck’s Welireg Cleared for Rare Tumors
The therapy is expected to be available by early September.
NSCLC Drug Trial Stopped Early After Strong Survival Results
Libtayo also reduced the risk of death by 29% compared with chemotherapy alone.
Second Specialty Pharmacy Chosen to Dispense Rezurock
The graft-versus-host disease therapy has also been added to NCCN Guidelines.
Exelixis Submits Cabometyx for Thyroid Cancer
The PDUFA date has been set for December 4, 2021; FDA has designated this as a Priority Review.
FDA Grants Keytruda Priority Review for Melanoma
The PDUFA date for this indication is December 4, 2021.
FDA Grants Tecentriq Priority Review for NSCLC
The FDA is expected to make a decision on this indication by December 1, 2021.
BMS Pulls Lymphoma Indication for Istodax
The therapy had received accelerated approval in 2011 but a phase 3 confirmatory trial found it did not meet the end point of progression-free survival.
Piqray’s Safety Label is Updated
Some fatal cases of ketoacidosis have occurred, and high-risk patients should be monitored when starting treatment.
Specialty Pharmacies Grapple with Assessing Costs and Value of Oncology Therapies
Drugs that provide only incremental benefit may not be included on clinical pathways.
Incyte Receives Complete Response Letter for Oncology Therapy
The FDA would like to see additional data on clinical benefit for patients with anal cancer.
Merck Vaccine and Other FDA Updates
Keytruda gets a full approval in endometrial cancer; while Xeljanz will miss another PDUFDA date.
NCCN Adds Jazz’s ALL Therapy Rylaze to Practice Guidelines
The June 30 approval meets an unmet need in this cancer.
Onco360 Chosen as Pharmacy Provider for Rezurock
The FDA had approved Kadmon's therapy for graft-versus-host disease July 16.
Jazz Pharmaceuticals Launches ALL Therapy Rylaze
The therapy is approved for both adults and children.
Keytruda Shows Positive Results in Early Stage, Triple-Negative Breast Cancer
Merck has submitted the data from the study KEYNOTE-522 to the FDA for review.
Study: Janssen’s Delay of Generics for Zytiga Achieved $2.05 Billion in Additional Sales
After generic entry, Zytiga’s market share fell to about 14% and monthly net sales across the entire market fell 85%.
CMS Provides Temporary Code for New Multiple Myeloma Therapy
A permanent code is expected in the third quarter of 2021.
Janssen Snags New Multiple Myeloma Indication for Darzalex Faspro
The new indication provides a subcutaneous option for multiple myeloma that can be administrated in minutes, rather than hours.
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