SPOTLIGHT -
FDA Approves Breyanzi for Additional Indication in Large B-Cell Lymphoma
Breyanzi is now available as a second-line treatment for this aggressive blood cancer.
Menarini Submits NDA Elacestrant for Advanced Breast Cancer
Elacestrant is oral therapy that targets estrogen receptor 1, a key resistance mechanism in advanced breast cancer.
FDA Approves Drug Combination for Tumor Agnostic Indication
The FDA approved the combination of Tafinlar and Mekinist for solid tumors with a BRAF V600E mutation. This is the first therapy to be approved that is tumor agnostic for patients with this mutation.
Study: The Cost-effectiveness of Polivy Depends on Outcomes
A study in the journal Blood has found that the cost-effectiveness of the Polivy treatment regimen used to treat patients with diffuse large B-cell lymphoma would decrease if the five-year progression-free survival decreased.
Clovis Oncology Pulls Rubraca Indication in Late-Stage Ovarian Cancer
Trial results showed overall survival was shorter compared with chemotherapy. The move doesn’t affect other indications.
Sierra Oncology Submits NDA For Momelotinib
Sierra Oncology is seeking approval of momelotinib as a treatment for patients with myelofibrosis, a bone marrow cancer.
Study: FDA Approves Oncology Drugs Faster than EMA
But investigators found that U.S. approvals often come before publication of results.
FDA Extends PDUFA Date for sNDA of Brukinsa
The FDA needs time to review additional clinical data submitted by BeiGene for the leukemia/lymphoma indication. The new date is Jan. 20, 2023.
FDA Accepts Keytruda Application for Earlier NSCLC After Surgery
The FDA has set a PDUFA date of Jan. 29, 2023, but Merck indicated additional data may be provided to regulators that extends this date.
Myovant Selects Onco360 as Specialty Pharmacy for Orgovyx
The FDA approved Orgovyx in December 2021 to treat patients with advanced prostate cancer.
BMS Updates Vidaza Label After Pediatric Indication Approval
The label now includes a new section about the risk of substituting an oral azacitidine product, Onureg, for the injection therapy.
IQVIA Finds New Cancer Clinical Trials are Increasing
More than 5,700 trials worldwide are investigating PD-1/PD-L1 inhibitors, and new trials of these therapies were of combination regimens.
FDA Withdraws Approval of Ukoniq
The FDA indicated the risk of death outweighs the benefits of Ukoniq, which was approved in February 2021 to treat specific lymphomas.
FDA Approves Two Opdivo Regimens for Metastatic Esophageal Cancer
Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers.
FDA Approves Kymriah for Adults with Follicular Lymphoma
Kymriah is now approved in three indications and is the only CAR-T cell therapy approved in both adult and pediatric settings.
New Global Coalition Aims to Improve Access to Cancer Medicines
The Access to Oncology Medicines Coalition brings together pharma companies and other organizations to help countries develop the capacity and access to essential cancer medicines.
FDA Approves Amneal’s Biosimilar of Neulasta
This is the fifth biosimilar of Neulasta and the third biosimilar from Amneal to receive FDA approval.
FDA Approves Tibsovo Combination for Older Patients with Leukemia
Tibsovo is the first therapy targeting cancer metabolism for patients with newly diagnosed IDH1-mutated acute myeloid leukemia.
Prime Therapeutics’ Biosimilar Program Cut Expenses by 26%
Launched last year, Prime’s MedDrive is an integrated drug management solution that leverages biosimilars to help reduce drug spend.
FDA Accepts BLA for Mirvetuximab Soravtansine for Ovarian Cancer
The FDA has set a Prescription Drug User Fee Act (PDUFA) action date of Nov. 28, 2022.
Analysis Finds 2020 Drug Approvals Based on Smaller, Less Rigorous Trials
While regulatory flexibility is important for drugs for rare diseases, investigators are concerned the trend toward surrogate endpoints decreases confidence that new drugs can improve patient outcomes.
Janssen Updates Warnings Section of Imbruvica Label
The label for Imbruvica now includes information about the possibility of cardiac failure, which has occurred in 1% of patients. Imbruvica is used to treat B-cell blood cancers.
Fresenius Kabi Launches Generic of Velcade
Bortezomib is part of the company’s KabiConnect program, a recent expansion of its KabiCare patient support program
AstraZeneca’s Blockbuster Cancer Drug Granted Priority Review for Rare Cancers
The FDA’s Prescription Drug User Fee Act action date for its regulatory decision for Imfinzi for BTC is during the third quarter of 2022.
FDA Approves Enhertu for Earlier Use in Metastatic Breast Cancer
The FDA’s accelerated approval of Enhertu in later line HER2 positive metastatic breast cancer has now converted to regular approval.
FDA Issues CRL for Surufatinib for Rare Pancreatic Cancer
The FDA would like Hutchmed to conduct a multi-regional trial that includes patients who are more representative of the U.S. patient population and aligned to current U.S. medical practice.
FDA Issues CRL for Toripalimab
The regulatory agency has requested a quality process change for toripalimab, which is being developed to treat nasopharyngeal carcinoma.
CVS Specialty, Elixir Among Pharmacies Distributing Cancer Drug Lenvima
Lenvima is approved to treat thyroid cancer, renal cell carcinoma and in combination with Keytruda for metastatic kidney cancer.
NCCN Adds Vonjo to Guidelines for Myeloproliferative Neoplasms
Vonjo is the first therapy that specifically addresses the needs of patients with cytopenic myelofibrosis, a bone marrow cancer.
Accord BioPharma Launches Camcevi for Advanced Prostate Cancer
Camcevi is the first ready-to-inject sterile formulation of leuprolide mesylate for subcutaneous injection that comes in a pre-filled syringe with no mixing required.
