May 31, 2022
On May 27, 2022, the U.S. Food and Drug Administration (FDA) approved both nivolumab in combination with fluoropyrimidine- and platinum-containing chemotherapy and nivolumab plus ipilimumab as a first-line treatment for adult patients with unresectable advanced or metastatic esophageal squamous cell carcinoma regardless of programmed death-ligand 1 (PD-L1) status.
For more information, read Bristol Myers Squibb's announcement .
Posted 5/31/2022
May 31, 2022
On May 28, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to tisagenlecleucel for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma after two or more lines of systemic therapy.
For more information, read Novartis' announcement .
Posted 5/31/2022
May 26, 2022
On May 25, 2022, the U.S. Food and Drug Administration (FDA) approved ivosidenib in combination with azacitidine for newly diagnosed acute myeloid leukemia with a susceptible IDH1 mutation, as detected by an FDA-approved test, in adults 75 years or older or who have comorbidities that preclude use of intensive induction chemotherapy.
Read the FDA announcement .
Read Servier's announcement .
Posted 5/26/2022
May 12, 2022
On May 10, 2022, it was announced that the Eisai lenvatinib dose exchange program has been expanded to cover all indicated dose reductions for patients with endometrial cancer who require a new prescription. The program will allow dose exchanges for up to 15 days of a patient's current dose for one that is lower, once per quarter, and at no cost.
For more information, read the news article .
Posted 5/12/2022
May 5, 2022
On May 4, 2022, the U.S. Food and Drug Administration (FDA) approved fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting, and who have developed disease recurrence during or within six months of completing therapy.
Read the FDA announcement .
Read AstraZeneca and Daiichi Sankyo's announcement .
Posted 5/5/2022
May 2, 2022
The American Society of Clinical Oncology (ASCO) has updated its 2022 guideline for biomarkers for adjuvant endocrine and chemotherapy in early-stage breast cancer to include the Oncotype DX Breast Recurrence Score ® test. This test is recommended for use in postmenopausal patients with up to three positive axillary lymph nodes, irrespective of clinical risk.
For more information, read Exact Sciences' announcement and the ASCO guideline update .
Posted 5/2/2022
April 18, 2022
On Monday, April 18, 2022, the U.S. Food and Drug Administration (FDA) approved Alymsys ® (bevacizumab-maly), a biosimilar to Avastin ® (bevacizumab). Alymsys' approved indications include:
Read Brand Institute's announcement for more information.
Posted 4/18/2022
April 14, 2022
Effective April 16, 2022, Secretary of Health and Human Services (HHS) Xavier Becerra renewed the COVID-19 public health emergency that has existed nationwide since January 27, 2020.
For more information, visit the HSS website .
Posted 4/14/2022
April 4, 2022
On Friday, April 1, 2022, the U.S. Food and Drug Administration (FDA) approved axicabtagene ciloleucel for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy.
Read the FDA announcement .
Read Gilead's announcement .
Posted 4/4/2022
March 24, 2022
On March 23, 2022, the U.S. Food and Drug Administration (FDA) approved lutetium Lu 177 vipivotide tetraxetan for the treatment of adult patients with prostate-specific membrane antigen-positive metastatic castration-resistant prostate cancer who have been treated with androgen receptor pathway inhibition and taxane-based chemotherapy.
Read the FDA announcement .
Read Novartis' announcement .
Posted 3/24/2022
March 22, 2022
On March 21, 2022, the U.S. Food and Drug Administration (FDA) approved pembrolizumab as a single agent for patients with advanced endometrial carcinoma that is microsatellite instability-high or mismatch repair deficient, as determined by an FDA-approved test, 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 Merck's announcement .
Posted 3/22/2022
March 21, 2022
On March 18, 2022, the U.S. Food and Drug Administration (FDA) approved nivolumab and relatlimab-rmbw for adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma.
Read the FDA announcement .
Read Bristol Myers Squibb's announcement .
Posted 3/21/2022
March 17, 2022
On Thursday, March 17, 2022, the U.S. Food and Drug Administration (FDA) approved the FoundationOne ® CDx to be used as a companion diagnostic to identify patients with non-small cell lung cancer whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) alterations and are appropriate for treatment with EGFR tyrosine kinase inhibitors that are approved by FDA for this indication.
Read Foundation Medicine's announcement .
Posted 3/17/2022
March 14, 2022
On March 11, 2022, the U.S. Food and Drug Administration (FDA) approved Myriad Genetics, Inc.'s BRACAnalysis ® CDx test for use as a companion diagnostic to identify patients with germline BRCA-mutated (gRBCAm) human epidermal growth factor receptor 2 (HER2)-negative, high-risk, early-stage breast cancer who may benefit from Lynparza ® (olaparib) (AstraZeneca).
Read the Myriad Genetics, Inc. announcement .
Posted 3/14/2022
March 14, 2022
On Friday, March 11, 2022, the U.S. Food and Drug Administration (FDA) approved olaparib for the adjuvant treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated (gBRCAm) human epidermal growth factor receptor 2 (HER2)-negative, high-risk, early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy.
Read the FDA announcement .
Read AstraZeneca's announcement .
Posted 3/14/2022
March 1, 2022
On Monday, February 28, 2022, the U.S. Food and Drug Administration (FDA) approved pacritinib for the treatment of adults with intermediate or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis with a platelet count below 50 × 10 9 /L.
Read CTI Biopharma's announcement .
Posted 3/1/2022
March 1, 2022
On Monday, February 28, 2022, the U.S. Food and Drug Administration (FDA) approved ciltacabtagene autoleucel for the treatment of adults with relapsed or refractory (R/R) multiple myeloma after four or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory agent, and an anti-CD38 monoclonal antibody.
Read Janssen's announcement .
Posted 3/1/2022
February 23, 2022
On February 16, 2022, the American Cancer Society's National Consortium for Cancer Screening and Care (ACS National Consortium) announced new cancer screening recommendations to accelerate recovery from the COVID-19 pandemic. These recommendations also look to improve the United States' ability to provide quality cancer screening and care for all.
The nine consensus recommendations include themes on:
Read the full list and details of the recommendations on the ACS website .
February 22, 2022
Foundation Medicine, Inc. announced that it received approval from the U.S. Food and Drug Administration (FDA) for the FoundationOne ® CDx to be used as a companion diagnostic to identify patients with microsatellite instability high (MSI-H) status solid tumors who may be appropriate for treatment with Merck’s Keytruda ® (pembrolizumab).
Read the Foundation Medicine announcement .
Posted 2/22/2022
February 14, 2022
Starting today, February 14, 2022, Tibsovo ® (ivosidenib tablets) will use NDC number 72694-0617-6 for ordering. Though the product packing has changed, Servier ensures the product and ordering process remain the same.
For more information, visit the Tibsovo website .
Posted 2/14/2022
January 26, 2022
On Wednesday, January 26, 2022, the U.S. Food and Drug Administration (FDA) approved tebentafusp-tebn for the treatment of HLA-A*02:01-positive adult patients with unresectable or metastatic uveal melanoma.
Read Immunocore's announcement .
Posted 1/26/2022
December 20, 2021
On December 20, 2021, the U.S. Food and Drug Administration (FDA) approved Illuccix ® , a kit for the preparation of gallium-68 (68Ga) gozetotide (also known as PSMA-11) injection, which is a radioactive diagnostic agent indicated for positron emission tomography of prostate-specific membrane antigen positive lesions in patients with prostate cancer with:
For more information, read Telix Pharmaceuticals' announcement .
December 16, 2021
GlaxoSmithKline (GSK) launched its new campaign Target the Future to address the current challenges patients with multiple myeloma and healthcare providers face. This campaign will provide education, identify key challenges the multiple myeloma community faces, and facilitate solutions to create a better future for patients, caregivers, and loved ones.
A component of this campaign is the Target the Future Think Tank Challenge , which is now accepting idea submissions. The winner will receive a $100,000 grant to bring their idea to life.
For more information on this campaign and how you can get involved, read GSK's announcement .
Posted 12/16/2021
December 10, 2021
On December 9, 2021, the U.S. Food and Drug Administration (FDA) granted premarket approval to Oncomine Dx Target Test as a companion diagnostic (CDx) to help identify patients with non-small cell lung cancer whose tumors carry epidermal growth factor receptor Exon20-insertion mutations for potential treatment with Rybrevant ® (amivantamab-vmjw).
Read ThermoFisher Scientific's announcement .
Posted 12/10/2021