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
July 22, 2021
On July 22, 2021, the U.S. Food and Drug Administration (FDA) approved the combination of pembrolizumab plus lenvatinib for the treatment of patients with advanced endometrial carcinoma that is not microsatellite instability-high or mismatch repair deficient, who have disease progression following prior systemic therapy in any setting and who are not candidates for curative surgery or radiation.
Read the FDA announcement .
Read the Merck announcement .
Read the Eisai Inc. announcement .
Posted 7/22/2021
July 20, 2021
On July 19, 2021, the Centers for Medicare & Medicaid Services (CMS) released the CY2022 Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems (OPPS/ASC) Notice of Proposed Rulemaking (CMS-1753-P) . The proposal includes items related to the Radiation Oncology (RO) Model.
The RO Model is proposed to start January 1, 2022, and run for five performance years.
The proposed CY2022 OPPS/ASC rules include the following RO Model proposals:
Read the full CMS Notice online . For more information on the RO Model, visit its website .
Posted 7/20/2021
July 19, 2021
On July 16, 2021, the U.S. Food and Drug Administration (FDA) approved belumosudil, a kinase inhibitor, for adult and pediatric patients 12 years and older with chronic graft-versus-host disease (GVHD) after failure of at least two prior lines of systemic therapy.
Read the FDA announcement .
Read the Kadmon Holdings, Inc. announcement .
Posted 7/19/2021
July 12, 2021
On July 9, 2021, the U.S. Food and Drug Administration (FDA) approved daratumumab and hyaluronidase-fihj in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma (MM) who have received at least one prior line of therapy including lenalidomide and a proteasome inhibitor.
Read the FDA announcement .
Read Janssen's announcement .
Posted 7/12/2021
July 6, 2021
On July 6, 2021, the U.S. Food and Drug Administration (FDA) approved an expanded label for pembrolizumab as a monotherapy treatment for patients with locally advanced cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation.
Read Merck's announcement .
Posted 7/6/2021
July 1, 2021
On July 1, 2021, the U.S. Food and Drug Administration (FDA) approved FoundationOne CDx as a companion diagnostic for brigatinib, which is currently FDA-approved for the treatment of adult patients with anaplastic lymphoma kinase-positive metastatic non-small cell lung cancer as detected by an FDA-approved test.
Read the Foundation Medicine announcement .
Posted 7/1/2021