Subscribe
Home
Issues
2024
February 2024 - Vol 17 No 1
2023
December 2023 - Vol 16 No 6
October 2023 - Vol 16 No 5
August 2023 - Vol 16 No 4
June 2023 - Vol 16 No 3
April 2023 - Vol 16 No 2
February 2023 - Vol 16 No 1
Issue Archive
Special Issues
Supplements
Guide to New FDA Approvals
Categories
Conference Correspondent
ESMO 2023 - Small Cell Lung Cancer
ONS 2023 - Multiple Myeloma: Wrap-Up
Web Exclusives
OFS Summit
Interview with the Innovators
Drug Updates
Media Library
Videos
Rapid Reactions
Audiocasts
Ask the Experts
Master Class Series
Resources
Quick Quiz
CE
Authors
Yvette Florio Lane
Digital Editor
The Lynx Group
Cranbury, NJ
Authored Items
Keytruda Approved for Patients with Previously Treated Metastatic Small-Cell Lung Cancer
By
Yvette Florio Lane
Web Exclusives
FDA Updates
,
In the News
Lung cancer is the second most frequently diagnosed malignancy in both men and women (following prostate and breast cancer, respectively), and the leading cause of cancer deaths overall. Non–small-cell lung cancer (NSCLC) is the most common type, with the more aggressive small-cell lung cancer (SCLC) making up approximately 10% to 15% of cases.
First Chemoimmunotherapy Regimen Granted Accelerated Approval for Patients with Previously Treated DLBCL
By
Yvette Florio Lane
Web Exclusives
FDA Updates
,
In the News
On June 10, 2019, the US Food and Drug Administration (FDA) granted accelerated approval to the novel antibody-drug conjugate polatuzumab vedotin-piiq (Polivy; Genentech) in combination with bendamustine plus rituximab for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) that has progressed or returned after at least 2 previous therapies. This is the first chemoimmunotherapy regimen approved for use in patients with DLBCL who are ineligible for hematopoietic stem-cell transplantation.
FDA Expands Indication for Kadcyla to Include the Adjuvant Treatment of HER2-Positive Early Breast Cancer
By
Yvette Florio Lane
Web Exclusives
Breast Cancer
,
FDA Updates
,
In the News
On May 3, 2019, the US Food and Drug Administration (FDA) approved ado-trastuzumab emtansine (Kadcyla; Genentech) for the adjuvant treatment of patients with HER2-positive early breast cancer who have residual invasive disease after neoadjuvant taxane and trastuzumab-based treatment. Patients should be selected for treatment with this agent based on an FDA-approved companion diagnostic test (Ventana Medical System’s PATHWAY anti-HER-2/neu [4B5] Rabbit Monoclonal Primary Antibody assay or INFORM HER2 Dual ISH DNA Probe Cocktail assay).
Tibsovo Now FDA Approved as First-Line Treatment for AML with IDH1 Mutation
By
Yvette Florio Lane
Web Exclusives
FDA Updates
,
In the News
On May 2, 2019, the US Food and Drug Administration (FDA) approved ivosidenib (Tibsovo; Agios Pharmaceuticals, Inc) for the treatment of newly diagnosed acute myeloid leukemia (AML) with a susceptible
IDH1
mutation, as detected by an FDA-approved companion diagnostic test, in patients who are aged ≥75 years or who have comorbidities that preclude the use of intensive induction chemotherapy.
FDA Approves Pembrolizumab plus Axitinib for Advanced Renal-Cell Carcinoma
By
Yvette Florio Lane
Web Exclusives
FDA Updates
,
In the News
,
Renal-Cell Carcinoma
Another Approval for Keytruda
April 16, 2019 – FDA Approvals, News & Updates
By
Yvette Florio Lane
Web Exclusives
FDA Updates
,
In the News
,
Lung Cancer
FDA Approves Keytruda for First-Line Treatment of Non–Small-Cell Lung Cancer (TPS ≥1%)
FDA Advises Women to Avoid Pregnancy for Only 2 Months After Final Dose of Soltamox
FDA Approves First Hormonal-Based Therapy for Men with Advanced or Metastatic Breast Cancer
By
Yvette Florio Lane
Web Exclusives
Breast Cancer
,
FDA Updates
,
In the News
On April 4, 2019, the US Food and Drug Administration (FDA) expanded the indication of palbociclib (Ibrance; Pfizer), a kinase inhibitor, in combination with specific endocrine therapies for men with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. This is the first hormonal-based therapy to be approved for men.
Proposed Landmark Policy Changes to Modernize Mammography and Raise Breast Density Awareness
By
Yvette Florio Lane
Web Exclusives
Breast Cancer
,
FDA Updates
,
In the News
On March 27, 2019, the US Food and Drug Administration (FDA) issued an alert from its Office of Women’s Health announcing that, after more than 20 years of regulatory oversight, the agency is proposing amendments to the existing policy governing mammography services.
FDA Approves Tecentriq plus Chemotherapy for First-Line Treatment of Extensive-Stage Small-Cell Lung Cancer
By
Yvette Florio Lane
Web Exclusives
FDA Updates
,
In the News
,
Lung Cancer
For the second time this month, the FDA has given an approval to Genentech’s PD-L1 inhibitor, Tecentriq.
FDA Approves Tecentriq plus Abraxane—First Immunotherapy for PD-L1– Positive Unresectable Locally Advanced or Metastatic Triple-Negative Breast Cancer
By
Yvette Florio Lane
Web Exclusives
FDA Updates
,
In the News
On March 8, 2019, the FDA granted accelerated approval to Genentech’s Tecentriq (atezolizumab), in combination with nab-paclitaxel (Abraxane), for the treatment of PD-L1–positive unresectable locally advanced or metastatic triple-negative breast cancer (TNBC). This marks the first time an immunotherapy drug has been granted approval for the treatment of any form of breast cancer.
March 08, 2019 – FDA Approvals, News & Updates
By
Yvette Florio Lane
Web Exclusives
FDA Updates
,
In the News
Approvals for new delivery methods for Herceptin and Cinvanti, and a new indication for Lonsurf close out the month of February in the FDA’s oncology-related activity.
FDA Approves Pembrolizumab for Treatment of Advanced Melanoma
By
Yvette Florio Lane
Web Exclusives
FDA Updates
,
In the News
On February 15, 2019, the US Food and Drug Administration (FDA) approved the immunotherapy agent pembrolizumab (Keytruda; Merck) for the adjuvant treatment of patients with resected stage III melanoma. This was the fourth approval pembrolizumab has received in the United States for the treatment of skin cancer, and the first FDA approval in the adjuvant setting.
FDA Approves Split-Dosing Regimen for Daratumumab in Patients with Multiple Myeloma
By
Yvette Florio Lane
Web Exclusives
FDA Updates
,
In the News
On February 12, 2019, the US Food and Drug Administration (FDA) granted approval for daratumumab (Darzalex; Janssen), a CD38-directed antibody, to be given in a split-dosing regimen to patients with multiple myeloma (MM). Darzalex is the first and only CD38-directed antibody to receive regulatory approval for the treatment of patients with MM and is the first to be approved for the split-dosing regimen. This new regimen gives patients and healthcare providers the option to split the first dose of Darzalex over the course of 2 consecutive days, which has the benefit of shortening the duration of the first infusion.
February 8, 2019 - FDA Approvals, News & Updates
By
Yvette Florio Lane
Web Exclusives
FDA Updates
,
In the News
FDA Approves First Therapy for the Treatment of Adult Patients with a Rare Blood Clotting Disorder
FDA Issues Letter to Healthcare Providers Alerting Them to a Risk for Breast Implant Associated–Anaplastic Large-Cell Lymphoma
February 1, 2019 - FDA Approvals, News & Updates
By
Yvette Florio Lane
Web Exclusives
FDA Updates
,
In the News
FDA Resumes Operations After Government Shutdown Ends
FDA Approves New Drug Indication for Use in Hepatocellular Carcinoma
FDA Approves Pembrolizumab for Merkel-Cell Carcinoma
Government Shutdown Impacts FDA Drug Approvals
By
Yvette Florio Lane
Web Exclusives
FDA Updates
,
In the News
Now in its fourth week, the longest shutdown in the history of the federal government is having an impact on patient care, as the US Food and Drug Administration (FDA) has put drug reviews and approvals for new drugs and devices, as well as the issuance of new guidance documents, on indefinite hold.
View the Latest Issue of TON
Read Issue
Home
Issues
2024
February 2024 - Vol 17 No 1
2023
December 2023 - Vol 16 No 6
October 2023 - Vol 16 No 5
August 2023 - Vol 16 No 4
June 2023 - Vol 16 No 3
April 2023 - Vol 16 No 2
February 2023 - Vol 16 No 1
Issue Archive
Special Issues
Supplements
Guide to New FDA Approvals
Categories
Conference Correspondent
ESMO 2023 - Small Cell Lung Cancer
ONS 2023 - Multiple Myeloma: Wrap-Up
Web Exclusives
OFS Summit
Interview with the Innovators
Drug Updates
Media Library
Videos
Rapid Reactions
Audiocasts
Ask the Experts
Master Class Series
Resources
Quick Quiz
CE
Subscribe Today!
To sign up for our newsletter or print publications, please enter your contact information below.
I'd like to receive:
TON
Print Edition
TON
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
TON
's
Privacy Policy
, and
TON
has my permission to retain my information in its database, and to forward pertinent communications to me.
START YOUR SUBSCRIPTION