November 18, 2021
On November 17, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.
Read the FDA announcement .
Read Merck's announcement .
Posted 11/18/2021
November 16, 2021
On Monday, November 15, 2021, the United States Multi-Society Task Force (MSTF) on Colorectal Cancer released updated screening recommendations. The Task Force now suggests that colorectal cancer screening starts in average-risk individuals age 45 to 49. This update is aligned with multiple other professional societies, including the United States Preventative Services Task Force, National Comprehensive Cancer Network, and American Cancer Society.
Unchanged recommendations from their 2017 update include:
The Multi-Society Task Force on Colorectal Cancer is represented by the American College of Gastroenterology , American Gastroenterological Association , and American Society for Gastrointestinal Endoscopy .
Full recommendations were published online via Gastrointestinal Endoscopy , Gastroenterology , and TheAmerican Journal of Gastroenterology . All articles will be available in January 2022 print issues.
Posted 11/16/2021
November 15, 2021
On November 12, 2021, the U.S. Food and Drug Administration (FDA) approved ropeginterferon alfa-2b-njft for the treatment of adults with polycythemia vera.
Read the FDA announcement .
Read PharmaEssentia's announcement for more information.
Posted 11/15/2021
November 3, 2021
On November 2, 2021, the Centers for Medicare & Medicaid Services (CMS) released the CY 2022 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems final rule (CMS-1753-F) . This announcement includes the finalized modifications to the Radiation Oncology (RO) Model.
The RO Model is set to begin January 1, 2022, and end December 31, 2026. The proposed rule includes the summarized modifications below:
For additional information on the RO Model and CMS' final rules, visit the RO Model website or read more on the final rule . For questions on the model or for participants needing their model ID, contact RadiationTherapy@cms.hhs.gov .
Posted 11/3/2021
November 1, 2021
On October 29, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to asciminib for patients with Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, previously treated with two or more tyrosine kinase inhibitors, and approved asciminib for adult patients with Ph+ CML in chronic phase with the T315I mutation.
Read the FDA announcement .
Read Novartis' announcement .
Posted 11/1/2021
October 20, 2021
Adaptive Biotechnologies launched an enhanced version of its clonoSEQ ® B-cell Clonality report. It will now feature the immunoglobulin heavy chain variable gene mutation status for patients with chronic lymphocytic leukemia (CLL).
The clonoSEQ assay was approved by the U.S. Food and Drug Administration to detect and monitor minimal residual disease in the blood or bone marrow of patients with CLL.
For more information on the clonoSEQ assay and its enhancements, read the Adaptive Biotechnologies announcement .
Posted 10/19/2021
October 18, 2021
On October 15, 2021, U.S. the Food and Drug Administration (FDA) approved atezolizumab for adjuvant treatment following resection and platinum-based chemotherapy in patients with Stage II to IIIA non-small cell lung cancer (NSCLC) whose tumors have PD-L1 expression on ≥ 1% of tumor cells, as determined by an FDA-approved test.
Read the FDA announcement .
Read Roche's announcement .
Posted 10/18/2021
October 14, 2021
On October 13, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (CPS ≥1), as determined by an FDA-approved test.
Read the FDA announcement .
Read Merck's announcement .
Posted 10/14/2021
October 14, 2021
On October 12, 2021, the U.S. Food and Drug Administration (FDA) approved abemaciclib with endocrine therapy (tamoxifen or an aromatase inhibitor) for adjuvant treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score greater than or equal to 20 percent, as determined by an FDA approved test.
Read the FDA announcement .
Read Eli Lilly and Company's announcement .
Posted 10/14/21
October 4, 2021
On October 1, 2021, the U.S. Food and Drug Administration (FDA) approved brexucabtagene autoleucel for adult patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (ALL).
Read the FDA announcement .
Read Kite Pharma's announcement .
Posted 10/4/2021
October 1, 2021
G1 Therapeutics announced the new permanent Healthcare Common Procedure Coding System (HCPCS) J-code for Cosela™ (trilaciclib) issued by the Centers for Medicare & Medicaid Services (CMS). The code J1448 is effective October 1, 2021, for trilaciclib injection of 1mg for provider billing at all sites of care.
Read more on the Cosela website or G1 Therapeutics announcement .
Posted 10/1/2021
September 29, 2021
On September 28, 2021, the U.S. Food and Drug Administration (FDA) granted approval of a new indication for cetuximab in combination with encorafenib for the treatment of adult patients with metastatic colorectal cancer with a BRAF V600E mutation, as detected by an FDA-approved test, after prior therapy.
Read Eli Lilly's announcement .
Posted 9/29/2021
September 21, 2021
On September 16, 2021, Bayer Healthcare released data from three subset analyses and one matching-adjusted indirect comparison model for Vitrakvi ® (larotrectinib). These reports showcase the product's clinical profile and add to its safety data for patients with solid tumors harboring an NTRK gene fusion, which is also known as TRK fusion cancer.
Key elements of Bayer's news includes:
"These analyses add to the body of evidence for the compound, which has the largest dataset and longest follow-up of any TRK inhibitor," says Bayer.
Read more at Bayer Healthcare's website .
Posted 9/21/2021
September 21, 2021
On September 20, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisotumab vedotin-tftv for the treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or after chemotherapy.
Read the FDA announcement .
Read Seagen and Genmab's announcement .
Posted 9/21/2021
September 16, 2021
On September 15, 2021, the U.S. Food and Drug Administration (FDA) approved mobocertinib for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations as detected by an FDA-approved test, whose disease has progressed on or after platinum-based chemotherapy.
Read the FDA announcement .
Read Takeda's announcement .
Posted 9/16/2021
September 15, 2021
On September 15, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to zanubrutinib for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen.
Read the FDA announcement .
Read BeiGene's announcement .
Posted 9/15/2021
September 7, 2021
On August 31, 2021, the U.S. Food and Drug Administration (FDA) approved zanubrutinib for adult patients with Waldenström’s macroglobulinemia.
Read the FDA announcement .
Read BeiGene's announcement .
Posted 9/7/2021
September 1, 2021
On August 31, 2021, the U.S. Food and Drug Administration (FDA) approved a label update to pembrolizumab for first-line advanced urothelial carcinoma (UC). This approval converts the accelerated approval of pembrolizumab to a regular approval.
Read Merck's announcement .
Posted 9/1/2021
August 27, 2021
On August 25, 2021, the U.S. Food and Drug Administration (FDA) granted pre-market approval to Oncomine Dx Target Test as a companion diagnostic to identify patients with isocitrate dehydrogenase-1 (IDH1) mutated cholangiocarcinoma who may be candidates for Tibsovo ® (ivosidenib) ( Servier Pharmaceuticals ).
Read the Thermo Fisher Scientific announcement .
Posted 8/27/2021
August 24, 2021
Oncopeptides announces J-code J9247 for Pepaxto ® (melphalan flufenamide) injection, 1mg. This J-code will be effective on October 1, 2021.
August 20, 2021
On August 19, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab—240 mg every two weeks or 480 mg every four weeks—for the adjuvant treatment of patients with urothelial carcinoma who are at high risk of recurrence after undergoing radical resection, regardless of prior neoadjuvant chemotherapy, nodal involvement, or programmed death-ligand 1 (PD-L1) status.
Read the FDA announcement .
Posted 8/20/2021
August 16, 2021
On August 13, 2021, the U.S. Food and Drug Administration (FDA) approved belzutifan, a hypoxia-inducible factor inhibitor, for adult patients with von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery.
Read the FDA announcement .
Read the Merck announcement .
Posted 8/16/2021
August 16, 2021
On August 10, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of lenvatinib plus pembrolizumab for first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
Read the FDA announcement .
Read the Eisai announcement .
Posted 8/16/2021
July 27, 2021
On July 27, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the treatment of patients with high-risk, early-stage triple-negative breast cancer (TNBC) in combination with chemotherapy as neoadjuvant treatment and then continued as a single agent as adjuvant treatment after surgery.
Read Merck's announcement .
Posted 7/27/2021