SPOTLIGHT -
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.
Keytruda Approved for Cutaneous Squamous Cell Carcinoma
This approval comes days after Merck announced it would withdraw indication for third-line gastric cancer.
The FDA Approves Rylaze for Leukemia and Lymphoma
The therapy, a recombinant version, was developed to address supply and manufacturing issues.
Immunotherapy Multikine Shows Benefit in Patients with Head and Neck Cancer
But there is no benefit for patients receiving chemotherapy.
Yescarta Meets Endpoints in Second-line DLBCL; Supplemental BLA Planned
Kite plans to submit a supplemental BLA based on these findings.
Bayer Introduces Updated Packaging for Stivarga
The anticancer therapy is now available in 21-count bottles to help accommodate dispensing.
Novel Immunotherapy Receives Breakthrough Designation in Advanced Melanoma
The therapy is a modified poliovirus vaccine that not only kills cancer cells but also can trigger long-term immune memory.
Reducing Cardiac Toxicity During Cancer Treatment
Chances of left ventricular ejection fraction almost disappeared when patient took the ACE-inhibitor lisinopril during treatment with trastuzumab/anthracycline, according to research presented at ASCO.
ASCO Abstracts Focus on Adverse Events of Checkpoint Inhibitors
Immune-related AEs can occur one to two years after treatment, are more common in combination treatments, and can be difficult to manage.
FDA OKs first targeted therapy for lung cancer with certain type of EGFR mutations
About 2% to 3% of patients with nonsmall cell lung cancer have EGFR exon 20 insertion mutations targeted by newly approved Rybrevant.
BMS’s Opdivo earns indication for gastric cancer
Opdivo is the first FDA-approved immunotherapy for the first-line treatment of gastric cancer.
Roche withdraws bladder cancer indication for blockbuster Tecentriq
The decision by Roche comes shortly after AstraZeneca withdrew the bladder cancer indication for durvalumab (Imfinzi).
FDA OKs Cosela, first-in-class therapy to protect bone marrow after chemotherapy
FDA clears BMS CAR-T cell therapy, Merck MET inhibitor
One of the new treatments available is a CAR-T cell therapy to treat relapsed or refractory large B-cell lymphoma.
