Subscribe
Home
Issues
Latest Issue
Issue Archive
Special Issues
Browse By Topic
Personalized Medicine
Economics & Value
FDA Approvals, News & Updates
COVID-19
Cholangiocarcinoma
View All Topics ›
Conference Correspondent
ASCO 2023 - Breast Cancer
AMCP Nexus 2022
ASCO 2022 - Wrap Up
Web Exclusives
Web Exclusive Articles
Videos
Interview with the Innovators
Prostate Cancer Diagnostics Monthly Minutes
Webinars
Quick Quizzes
Press Releases
AVBCC
Association for Value-Based Cancer Care
VBCM
Value-Based Care in Myeloma
Browse By Topic
FDA Approvals, News & Updates
FDA Approvals, News & Updates
FDA Approves Columvi for Select Patients With Relapsed or Refractory Large B-Cell Lymphomas
FDA Approvals, News & Updates
,
Lymphoma
,
Hematologic Malignancies
August 2023, Vol 14, No 4
On
June 15, 2023
, the FDA accelerated the approval of glofitamab-gxbm (Columvi; Genentech), a bispecific CD20-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma, not otherwise specified, or large B-cell lymphoma arising from follicular lymphoma after ≥2 lines of systemic therapy.
Read Article
Epkinly FDA Approved for Treatment of Advanced Diffuse Large B-Cell Lymphoma
FDA Approvals, News & Updates
,
Lymphoma
,
Hematologic Malignancies
August 2023, Vol 14, No 4
On
May 19, 2023
, the FDA accelerated the approval of epcoritamab-bysp (Epkinly; Genmab US), a bispecific CD20-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from indolent lymphoma, or high-grade B-cell lymphoma after ≥2 lines of systemic therapy.
Read Article
Lonsurf Receives New Indication, in Combination With Bevacizumab, for Previously Treated Metastatic Colorectal Cancer
FDA Approvals, News & Updates
,
Colorectal Cancer
August 2023, Vol 14, No 4
On
August 2, 2023
, the FDA approved a new indication for trifluridine and tipiracil (Lonsurf; Taiho Oncology), in combination with bevacizumab (Avastin), for metastatic colorectal cancer previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy; an anti–vascular endothelial growth factor biologic therapy; and if
RAS
wild-type, an anti–epidermal growth factor receptor therapy.
Read Article
Jemperli Plus Chemotherapy Now FDA Approved for Front-Line Treatment of dMMR or MSI-H Endometrial Cancer
FDA Approvals, News & Updates
,
Endometrial Cancer
,
Gynecologic Cancer
August 2023, Vol 14, No 4
On
July 31, 2023
, the FDA approved a new indication for dostarlimab-gxly (Jemperli; GlaxoSmithKline), a PD-1 inhibitor, in combination with carboplatin and paclitaxel, followed by single-agent dostarlimab, for primary advanced or recurrent endometrial cancer that is mismatch repair deficient (dMMR), as determined by an FDA-approved test, or microsatellite instability-high (MSI-H).
Read Article
Vanflyta Now Approved for Newly Diagnosed FLT3-ITD–Positive AML
FDA Approvals, News & Updates
,
Leukemia
,
Hematologic Malignancies
August 2023, Vol 14, No 4
On
July 20, 2023
, the FDA approved quizartinib (Vanflyta; Daiichi Sankyo) with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy after consolidation chemotherapy, for the treatment of adults with newly diagnosed acute myeloid leukemia (AML) that is
FLT3
-internal tandem duplication (
ITD
)–positive, as detected by an FDA-approved test.
Read Article
Talzenna Receives New Indication, With Enzalutamide, for Metastatic Castration-Resistant Prostate Cancer With HRR Gene Mutation
FDA Approvals, News & Updates
,
Prostate Cancer
August 2023, Vol 14, No 4
On
June 20, 2023
, the FDA approved a new indication for talazoparib (Talzenna; Pfizer), a poly (ADP-ribose) polymerase inhibitor, in combination with enzalutamide (Xtandi; Astellas) for homologous recombination repair (
HRR
) gene mutation–positive, metastatic castration-resistant prostate cancer. The FDA granted this application priority review.
Read Article
Tornado Sweeps Through Pfizer’s Storage and Manufacturing Facility
FDA Approvals, News & Updates
Web Exclusives
On July 19, 2023, an EF3 tornado touched down in Rocky Mount, NC, badly damaging a Pfizer drug manufacturing facility that is responsible for producing nearly 25% of Pfizer’s sterile injectable medicines used in US hospitals.
Read Article
Zynyz Receives FDA Accelerated Approval for Merkel-Cell Carcinoma
FDA Approvals, News & Updates
,
Skin Cancer
April 2023, Vol 14, No 2
On
March 22, 2023
, the FDA granted accelerated approval to retifanlimab-dlwr (Zynyz; Incyte Corporation), a programmed cell death 1–blocking antibody, for the treatment of adult patients with metastatic or recurrent locally advanced Merkel-cell carcinoma.
Read Article
Tafinlar plus Mekinist Combination Approved for Pediatric Low-Grade Glioma with BRAFᵛ⁶⁰⁰ᴱ Mutation
FDA Approvals, News & Updates
,
Head and Neck Cancer
April 2023, Vol 14, No 2
On
March 16, 2023
, the FDA approved dabrafenib (Tafinlar; Novartis) in combination with trametinib (Mekinist; Novartis) for the treatment of pediatric patients aged ≥1 year with low-grade glioma that harbors a
BRAF
V600E
mutation and who require systemic therapy.
Read Article
FDA Expands Indication for Verzenio as Adjuvant Treatment for HR-Positive, HER2-Negative, Early Breast Cancer
FDA Approvals, News & Updates
,
Breast Cancer
April 2023, Vol 14, No 2
On
March 3, 2023
, the FDA approved abemaciclib (Verzenio; Eli Lilly) plus endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adult patients with hormone receptor (HR)-positive,
HER2
-negative, node-positive, early breast cancer at high risk for recurrence.
Read Article
Page 1 of 35
1
2
3
4
5
6
7
8
9
10
View the Latest Issue of VBCC
Read Issue
Top Trending Articles
1.
Liquid Biopsies on the Horizon for Children With Solid Cancers
Ella Ben-Ari
2.
Improving Diversity in Clinical Trials
Phoebe Starr
3.
Physician Debate: Is Chemotherapy Still the Backbone for CCA Treatment?
Home
Issues
Latest Issue
Issue Archive
Special Issues
Browse By Topic
Personalized Medicine
Economics & Value
FDA Approvals, News & Updates
COVID-19
Cholangiocarcinoma
View All Topics ›
Conference Correspondent
ASCO 2023 - Breast Cancer
AMCP Nexus 2022
ASCO 2022 - Wrap Up
Web Exclusives
Web Exclusive Articles
Videos
Interview with the Innovators
Prostate Cancer Diagnostics Monthly Minutes
Webinars
Quick Quizzes
Press Releases
AVBCC
Association for Value-Based Cancer Care
VBCM
Value-Based Care in Myeloma
Subscribe Today!
To sign up for our newsletter or print publications, please enter your contact information below.
I'd like to receive:
VBCC
Print Edition
VBCC
Weekly e‑Newsletter
-- Please Select --
Afghanistan
Åland Islands
Albania
Algeria
American Samoa
Andorra
Angola
Anguilla
Antarctica
Antigua and Barbuda
Argentina
Armenia
Aruba
Australia
Austria
Azerbaijan
Bahamas
Bahrain
Bangladesh
Barbados
Belarus
Belgium
Belize
Benin
Bermuda
Bhutan
Bolivia, Plurinational State of
Bonaire, Sint Eustatius and Saba
Bosnia and Herzegovina
Botswana
Bouvet Island
Brazil
British Indian Ocean Territory
Brunei Darussalam
Bulgaria
Burkina Faso
Burundi
Cambodia
Cameroon
Canada
Cape Verde
Cayman Islands
Central African Republic
Chad
Chile
China
Christmas Island
Cocos (Keeling) Islands
Colombia
Comoros
Congo
Congo, the Democratic Republic of the
Cook Islands
Costa Rica
Côte d'Ivoire
Croatia
Cuba
Curaçao
Cyprus
Czech Republic
Denmark
Djibouti
Dominica
Dominican Republic
Ecuador
Egypt
El Salvador
Equatorial Guinea
Eritrea
Estonia
Ethiopia
Falkland Islands (Malvinas)
Faroe Islands
Fiji
Finland
France
French Guiana
French Polynesia
French Southern Territories
Gabon
Gambia
Georgia
Germany
Ghana
Gibraltar
Greece
Greenland
Grenada
Guadeloupe
Guam
Guatemala
Guernsey
Guinea
Guinea-Bissau
Guyana
Haiti
Heard Island and McDonald Islands
Holy See (Vatican City State)
Honduras
Hong Kong
Hungary
Iceland
India
Indonesia
Iran, Islamic Republic of
Iraq
Ireland
Isle of Man
Israel
Italy
Jamaica
Japan
Jersey
Jordan
Kazakhstan
Kenya
Kiribati
Korea, Democratic People's Republic of
Korea, Republic of
Kuwait
Kyrgyzstan
Lao People's Democratic Republic
Latvia
Lebanon
Lesotho
Liberia
Libya
Liechtenstein
Lithuania
Luxembourg
Macao
Macedonia, the former Yugoslav Republic of
Madagascar
Malawi
Malaysia
Maldives
Mali
Malta
Marshall Islands
Martinique
Mauritania
Mauritius
Mayotte
Mexico
Micronesia, Federated States of
Moldova, Republic of
Monaco
Mongolia
Montenegro
Montserrat
Morocco
Mozambique
Myanmar
Namibia
Nauru
Nepal
Netherlands
New Caledonia
New Zealand
Nicaragua
Niger
Nigeria
Niue
Norfolk Island
Northern Mariana Islands
Norway
Oman
Pakistan
Palau
Palestinian Territory, Occupied
Panama
Papua New Guinea
Paraguay
Peru
Philippines
Pitcairn
Poland
Portugal
Puerto Rico
Qatar
Réunion
Romania
Russian Federation
Rwanda
Saint Barthélemy
Saint Helena, Ascension and Tristan da Cunha
Saint Kitts and Nevis
Saint Lucia
Saint Martin (French part)
Saint Pierre and Miquelon
Saint Vincent and the Grenadines
Samoa
San Marino
Sao Tome and Principe
Saudi Arabia
Senegal
Serbia
Seychelles
Sierra Leone
Singapore
Sint Maarten (Dutch part)
Slovakia
Slovenia
Solomon Islands
Somalia
South Africa
South Georgia and the South Sandwich Islands
South Sudan
Spain
Sri Lanka
Sudan
Suriname
Svalbard and Jan Mayen
Swaziland
Sweden
Switzerland
Syrian Arab Republic
Taiwan, Province of China
Tajikistan
Tanzania, United Republic of
Thailand
Timor-Leste
Togo
Tokelau
Tonga
Trinidad and Tobago
Tunisia
Turkey
Turkmenistan
Turks and Caicos Islands
Tuvalu
Uganda
Ukraine
United Arab Emirates
United Kingdom
United States
United States Minor Outlying Islands
Uruguay
Uzbekistan
Vanuatu
Venezuela, Bolivarian Republic of
Viet Nam
Virgin Islands, British
Virgin Islands, U.S.
Wallis and Futuna
Western Sahara
Yemen
Zambia
Zimbabwe
I have reviewed and consent to the terms of
VBCC
's
Privacy Policy
, and
VBCC
has my permission to retain my information in its database, and to forward pertinent communications to me.
START YOUR SUBSCRIPTION