Drug Resource Links
Click Here for National Drug Code Directory
Click Here for Drug Discontinuations and Shortages
Click Here for assistPoint
Click Here for ACCC Drug Database
Latest Drug Updates
Posted April 16, 2021
On April 16, 2021, the Food and Drug Administration approved nivolumab (Opdivo, Bristol-Myers Squibb Company) in combination with fluoropyrimidine- and platinum-containing chemotherapy for advanced or metastatic gastric cancer, gastroesophageal junction cancer, and esophageal adenocarcinoma. Efficacy was evaluated in CHECKMATE-649 (NCT02872116), a randomized, multicenter, open-label trial that enrolled 1,581 patients with previously untreated advanced or metastatic...
Posted April 13, 2021
On April 13, 2021, the Food and Drug Administration granted accelerated approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with locally advanced or metastatic urothelial cancer (mUC) who previously received a platinum-containing chemotherapy and either a programmed death receptor-1 (PD-1) or a programmed death-ligand 1 (PD-L1) inhibitor. Efficacy and safety were evaluated in TROPHY...
Posted April 7, 2021
On April 7, 2021, the Food and Drug Administration granted regular approval to sacituzumab govitecan (Trodelvy, Immunomedics Inc.) for patients with unresectable locally advanced or metastatic triple-negative breast cancer (mTNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease. In April 2020, sacituzumab govitecan received accelerated approval...
Posted April 7, 2021
On April 6, 2021, the Food and Drug Administration approved a new dosage regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks (Q2W) for cetuximab (Erbitux, ImClone LLC) for patients with K-Ras wild-type, EGFR-expressing colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN). This approval provides for a biweekly...
Posted April 1, 2021
On March 31, 2021, the Food and Drug Administration approved isatuximab-irfc (Sarclisa, sanofi-aventis U.S. LLC) in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. The efficacy and safety of isatuximab-irfc in combination with carfilzomib and dexamethasone...
Posted March 23, 2021
On March 22, 2021, the Food and Drug Administration approved pembrolizumab (Keytruda, Merck Sharp & Dohme Corp.) in combination with platinum and fluoropyrimidine-based chemotherapy for patients with metastatic or locally advanced esophageal or gastroesophageal (GEJ) (tumors with epicenter 1 to 5 centimeters above the gastroesophageal junction) carcinoma who are not candidates for surgical resection or...
Posted March 11, 2021
Food and Drug Administration approved tivozanib (Fotivda, AVEO Pharmaceuticals, Inc.), a kinase inhibitor, for adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies. . March 10, 2021. More Information: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-tivozanib-relapsed-or-refractory-advanced-renal-cell-carcinoma
Posted March 8, 2021
On March 5, 2021, the Food and Drug Administration granted accelerated approval to axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) for adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy. Approval in FL was based on a single-arm, open-label, multicenter trial (ZUMA-5; NCT03105336) that evaluated axicabtagene ciloleucel, a...
Posted March 4, 2021
Action Advances Fight Against COVID-19, Follows Comprehensive Evaluation of Available Safety, Effectiveness and Manufacturing Quality Information by FDA Career Scientists, Input from External Experts Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome...
Posted March 4, 2021
WALTHAM — March 1, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announced that the U.S. Food and Drug Administration (FDA) has approved PEPAXTO® (melphalan flufenamide), known during clinical development as melflufen, in combination with dexamethasone, for the treatment of adult patients with relapsed or...
Posted March 4, 2021
The FDA has approved a supplemental new drug application for lorlatinib (Lorbrena) to expand the indication to include the frontline treatment of patients with ALK-positive non–small cell lung cancer (NSCLC) as detected by an FDA-approved test. The regulatory based on the data from the pivotal phase 3 CROWN trial (NCT03052608), where lorlatinib resulted in a 72%...
Posted March 1, 2021
Food and Drug Administration granted accelerated approval to melphalan flufenamide (Pepaxto, Oncopeptides AB) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD-38 directed monoclonal...
Posted February 25, 2021
(Sanofi) Feb 22, 2021 – The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (tumor proportion score ≥50%), as determined by an FDA-approved test. Read more >
Posted February 22, 2021
On February 22, 2021, the Food and Drug Administration approved cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) (locally advanced who are not candidates for surgical resection or definitive chemoradiation or metastatic) whose tumors have high PD-L1 expression (Tumor Proportion Score [TPS] > 50%) as determined by...
Posted February 11, 2021
PARIS and TARRYTOWN, N.Y. – February 9, 2021 – The U.S. Food and Drug Administration (FDA) has approved the PD-1 inhibitor Libtayo® (cemiplimab-rwlc) as the first immunotherapy indicated for patients with advanced basal cell carcinoma (BCC) previously treated with an hedgehog pathway inhibitor (HHI) or for whom an HHI is not appropriate. Full approval was granted...
Posted February 11, 2021
Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk...
Posted February 10, 2021
On February 9, 2021, the Food and Drug Administration granted regular approval to cemiplimab-rwlc (Libtayo, Regeneron Pharmaceuticals, Inc.) for patients with locally advanced basal cell carcinoma (laBCC) previously treated with a hedgehog pathway inhibitor (HHI) or for whom a HHI is not appropriate and granted accelerated approval to cemiplimab-rwlc for patients with metastatic BCC (mBCC)...
Posted February 9, 2021
On February 5, 2021, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc.) for the treatment of adult patients with relapsed or refractory (R/R) large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell...
Posted February 9, 2021
Today, the U.S. Food and Drug Administration approved Breyanzi (lisocabtagene maraleucel), a cell-based gene therapy to treat adult patients with certain types of large B-cell lymphoma who have not responded to, or who have relapsed after, at least two other types of systemic treatment. Breyanzi, a chimeric antigen receptor (CAR) T cell therapy, is the...
Posted February 5, 2021
On December 18, 2020, the Food and Drug Administration approved selinexor (XPOVIO, Karyopharm Therapeutics Inc.) in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy. Read More HERE>>
Posted February 4, 2021
On February 3, 2021, the Food and Drug Administration granted accelerated approval to tepotinib (Tepmetko, EMD Serono Inc.) for adult patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations. Efficacy was demonstrated in the VISION trial (NCT02864992), a multicenter, non-randomized, open-label, multicohort study enrolling 152 patients with advanced...
Posted January 28, 2021
(FDA.gov) Jan 22, 2021 – On January 22, 2021, the Food and Drug Administration approved the combination of nivolumab (Opdivo, Bristol-Myers Squibb Co.) and cabozantinib (Cabometyx, Exelixis) as first-line treatment for patients with advanced renal cell carcinoma (RCC). Efficacy was evaluated in CHECKMATE-9ER (NCT03141177), a randomized, open-label trial in patients with previously untreated advanced RCC....
Posted January 20, 2021
[1/15/21] The U.S. Food and Drug Administration is alerting health care professionals to labeling updates for the preparation of vinca alkaloids, a group of chemotherapy agents that includes vincristine sulfate injection, vinblastine sulfate (for) injection, and vinorelbine tartrate injection. To reduce the potential for unintended intrathecal (spinal) administration, which causes death or severe neurological injury, FDA...
Posted January 20, 2021
On January 15, 2021, the Food and Drug Administration approved fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) for adult patients with locally advanced or metastatic HER2-positive gastric or gastroesophageal (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen. Efficacy was evaluated in a multicenter, open-label, randomized trial (DESTINY-Gastric01, NCT03329690) in patients with HER2-positive locally advanced or metastatic...
Posted January 20, 2021
On January 14, 2021, the Food and Drug Administration approved crizotinib (Xalkori, Pfizer Inc.) for pediatric patients 1 year of age and older and young adults with relapsed or refractory, systemic anaplastic large cell lymphoma (ALCL) that is ALK-positive. The safety and efficacy of crizotinib have not been established in older adults with relapsed or...
Posted January 12, 2021
On December 18, 2020, the U.S. Food and Drug Administration (FDA) approved ORGOVYX (relugolix) for the treatment of adult patients with advanced prostate cancer. The approved recommended dosage of ORGOVYX is an initial loading dose of 360 mg on the first day and continue treatment with a 120 mg dose taken orally once daily at...
Posted December 17, 2020
The FDA granted approval to the Fc-engineered, monoclonal antibody margetuximab (MGAH22) in combination with chemotherapy, as treatment of adult patients with metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 regimens, at least one of which was for metastatic disease, according to a press release from MacroGenics, Inc.1 “Early detection and treatment...
Posted December 8, 2020
From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the...
Posted November 30, 2020
From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the...
Posted November 17, 2020
Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co.) in combination with chemotherapy for the treatment of patients with locally recurrent unresectable or metastatic triple-negative breast cancer (TNBC) whose tumors express PD-L1 (CPS ≥10) as determined by an FDA approved test. November 13, 2020. More Information: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-grants-accelerated-approval-pembrolizumab-locally-recurrent-unresectable-or-metastatic-triple
Posted November 9, 2020
From the American Society of Clinical Oncology in cooperation with the Food and Drug Administration (FDA) and as a service to our members, ASCO will periodically distribute information about newly approved therapies for cancer patients. This helps FDA inform oncologists and professionals in oncology-related fields about recent approvals in a timely manner. Included in the...
Posted November 5, 2020
OncLive (10/23) reported, “The FDA has approved the FoundationOne CDx (F1CDx)comprehensive genomic test as a companion diagnostic for larotrectinib (Vitrakvi) to identify patients with NTRK1/2/3 gene fusions across all solid tumors.” The test “is currently the sole FDA-approved tissue-based comprehensive genomic profiling assay that is indicated to detect NTRK1/2/3 fusions across all solid malignancies and identify...
Posted October 25, 2020
On October 22, 2020, the U.S. Food and Drug Administration (FDA) approved VEKLURY (remdesivir) for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization. VEKLURY should only be administered intravenously (IV) in a hospital or in a healthcare...
Posted October 22, 2020
On Friday, the FDA granted full approval for Venclexta (venetoclax) in combination with azacitidine, or decitabine, or low-dose cytarabine (LDAC) for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venclexta was previously granted provisional approval in this...
