FDA Approvees Fam-Trastuzumab Deruxtecan-nxki for HER2-Mutant NSCLC

On August 11, 2022, the U.S. Food and Drug Administration (FDA) granted accelerated approval to fam-trastuzumab deruxtecan-nxki for adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating human epidermal growth factor receptor 2 HER2 (ERBB2) mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

For more information, read the FDA announcement or the AstraZeneca and Daiichi Sankyo announcement.

Posted 8/15/2022

FDA Approves Capmatinib for Metastatic NSCLC

On August 10, 2022, the U.S. Food and Drug Administration (FDA) granted regular approval to capmatinib for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation leading to mesenchymal-epithelial transition (MET) exon 14 skipping, as detected by an FDA-approved test.

For more information, read the FDA announcement.

Posted 8/15/2022

FDA Approves New Acalabrutinib Formulation

On August 5, 2022, the U.S. Food and Drug Administration approved the new tablet formulation for acalabrutinib for all current indications, including chronic lymphocytic leukaemia, small lymphocytic lymphoma, and relapsed or refractory mantle cell lymphoma.

For more information, read AstraZeneca's announcement.

Posted 8/12/2022

Important Update: Olaparib in 4th Line Treatment of Ovarian Cancer

FDA Approves Fam-Trastuzumab-Deruxtecan-nxki for HER2-Low Breast Cancer

On August 5, 2022, the U.S Food and Drug Administration (FDA) approved fam-trastuzumab-deruxtecan-nxki for the treatment of patients with unresectable or metastatic HER2-low breast cancer.

For more information, read the FDA announcement .

Posted 8/5/2022

FDA Approves Tablet Formulation of Acalabrutinib

On August 5, 2022, the Food and Drug Administration approved new tablet formulation of acalabrutinib (Calquence, AstraZeneca) under accelerated approval based on overall response rate for all current indications, including adult patients with chronic lymphocytic leukemia, small lymphocytic lymphoma, and patients with relapsed or refractory mantle cell lymphoma.

Read full press release. 

Posted on 08/05/2022

BMS Launches DDiCT Initiative to Improve Healthcare Outcomes for People with Disabilities

FDA Approves Crizotinib for ALK-Positive Inflammatory Myofibroblastic Tumor

FDA Approves Dabrafenib + Trametinib for Metastatic Solid Tumors

FDA Approves Lisocabtagene Maraleucel for Refractory Large B-Cell Lymphoma

• Refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy
• Refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplant due to comorbidities or age.
  

FDA Approves Two Nivolumab-Based Regimens for Esophageal Squamous Cell Carcinoma

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

FDA Approves Tisagenlecleucel for R/R Follicular Lymphoma

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

Fam-Trastuzumab Deruxtecan-Nxki Approved for Patients with HER2+ MBC

Fam-Trastuzumab Deruxtecan-Nxki (Enhertu^®, Daiichi Sankyo, AstraZeneca) has been approved in the U.S. for the treatment of 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 have developed disease recurrence during or within six months of completing therapy.

Read press release. 

Posted 05/17/2022

FDA Approves Lutetium Lu 177 Vipivotide Tetraxetan for Prostate Cancer

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

FDA Approves Pembrolizumab for Advanced Endometrial Carcinoma

FDA approves nivolumab and relatlimab-rmbw for melanoma

FDA Approves Olaparib for High-Risk Early Breast Cancer

FDA Approves Nivolumab in Combination for Early-Stage NSCLC

FDA Approves Pembrolizumab for IIB or IIC Melanoma Following Complete Resection

On December 3, 2021, the U.S. Food and Drug Administration approved Keytruda^® (pembrolizumab) for the adjuvant treatment of adult and pediatric (greater than or equal to 12 years of age) patients with stage IIB or IIC melanoma following complete resection. 

Read the FDA announcement.

Read Merck's announcement.

Posted 12/6/2021

FDA Approves Pembrolizumab for Adjuvant Treatment of Renal Cell Carcinoma

On November 17, 2021, the U.S. Food and Drug Administration (FDA) approved pembrolizumab for the adjuvant treatment of patients with renal cell carcinoma at intermediate-high or high risk of recurrence following nephrectomy or following nephrectomy and resection of metastatic lesions.

Read the FDA announcement.

Read Merck's announcement.

Posted 11/18/2021