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
July 1, 2021
On June 30, 2021, the U.S. Food and Drug Administration (FDA) approved asparaginase erwinia chrysanthemi (recombinant)-rywn as a component of a multi-agent chemotherapy regimen for the treatment of acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in adult and pediatric patients who are allergic to the E. coli-derived asparaginase products used most commonly for treatment.
Read the FDA announcement .
Read the Jazz Pharmaceuticals announcement .
Posted 7/1/2021
June 25, 2021
On June 24, 2021, the U.S. Food and Drug Administration (FDA) issued drafted guidance that encourages the inclusion the patients with incurable cancers in clinical trials, regardless of their treatment history. When finalized, the FDA's guidance will "provide recommendations to sponsors designing clinical trials of drug and biological products to expand eligibility to patients with incurable cancers."
It will also provide guidance on how to address patients who have not received prior therapies, such as using separate cohorts.
Read the full FDA draft guidance for sponsors .
Posted 6/25/2021
June 17, 2021
On June 16, 2021, the U.S. Food and Drug Administration (FDA) approved avapritinib for the treatment of adult patients with advanced systemic mastocytosis (SM), including aggressive SM, SM with an associated hematological neoplasm, and mast cell leukemia.
Read the FDA announcement .
Read Blueprint Medicines' announcement .
Posted 06/17/2021
June 1, 2021
On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to infigratinib for adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.
Read the FDA announcement .
Read the QED Therapeutics announcement .
Posted 6/1/2021
June 1, 2021
On May 28, 2021, the U.S. Food and Drug Administration approved the Guardant360 ® CDx test for tumor mutation profiling or comprehensive genomic profiling to identify patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) who harbor the KRAS G12C mutation and may benefit from Lumakras™ (sotorasib), an FDA-approved KRASG12C inhibitor developed and manufactured by Amgen.
Read the Guardant Health announcement .
Posted 6/1/2021
June 1, 2021
On May 28, 2021, the U.S. Food and Drug Administration (FDA) granted accelerated approval to sotorasib for adult patients with KRAS G12C mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA approved test, who have received at least one prior systemic therapy.
Read the FDA announcement .
Read the Amgen announcement .
Posted 6/1/2021
May 24, 2021
On May 21, 2021, the U.S. Food and Drug Administration approved the Guardant360 ® CDx liquid biopsy test as the first and only companion diagnostic for amivantamab-vmjw.
The Guardant360 CDx test will be used for tumor mutation profiling or comprehensive genomic profiling to identify patients with locally advanced or metastatic non-small cell lung cancer who harbor the EGFR exon 20 insertion mutation and may benefit from targeted treatment with amivantamab-vmjw after progressing on or after platinum-based chemotherapy.
Read Guardant Health's announcement .
Posted 5/24/2021
May 21, 2021
On May 21, 2021, the U.S. Food and Drug Administration (FDA) approved mivantamab-vmjw as the first treatment for adult patients with non-small cell lung cancer (NSCLC) whose tumors have specific types of genetic mutations: epidermal growth factor receptor exon 20 insertion mutations.
Read the FDA announcement .
Posted 5/21/2021
May 20, 2021
On May 20, 2021, the U.S. Food and Drug Administration (FDA) approved nivolumab for patients with completely resected esophageal or gastroesophageal junction (GEJ) cancer with residual pathologic disease who have received neoadjuvant chemoradiotherapy.
Read the FDA announcement .
Read the Bristol Myers Squibb announcement .
Posted 5/21/2021