Drugs

FDA approved approved pembrolizumab colorectal cancer

• Amanda Bridges
• June 30, 2020
• Drugs
• No Comments

Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co.) for the first-line treatment of patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer. More Information. June 29, 2020 https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-pembrolizumab-first-line-treatment-msi-hdmmr-colorectal-cancer  Hematology/Oncology (Cancer) Approvals & Safety Notifications https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications

FDA Grants Approval to New Fixed-Dose Combination of Perjeta and Herceptin

• Amanda Bridges
• June 30, 2020
• Drugs
• No Comments

Genentech announced the FDA granted approval to Phesgo, a new fixed-dose combination of Perjeta and Herceptin available in a single vial. It can be administered under the skin (subcutaneous injection) in just minutes, significantly reducing the amount of time a patient spends receiving treatment when compared to hours with IV administration. The Genentech press release…

FDA approves pembrolizumab for cutaneous squamous cell carcinoma

• Amanda Bridges
• June 26, 2020
• Drugs
• No Comments

On June 24, 2020, the Food and Drug Administration approved pembrolizumab (KEYTRUDA®, Merck & Co., Inc.) for patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. Efficacy was investigated in KEYNOTE-629 (NCT03284424), a multicenter, multi-cohort, non-randomized, open-label trial. The trial excluded patients who had previously received…

FDA Approval of XPO1 Inhibitor Compound

• Katrina Williams
• June 24, 2020
• Drugs
• No Comments

Karyopharm Therapeutics Inc. is proud to announce the FDA approval of their lead XPO1 inhibitor compound to treat patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL). To learn more about this recent approval, please see the full press release here. (For XPOVIO®(selinexor) full Prescribing Information please visit: XPOVIO Full Prescribing Information.)

FDA granted accelerated approval to tazemetostat for follicular lymphoma

• FLASCO
• June 23, 2020
• Drugs
• No Comments

On June 18, 2020, the Food and Drug Administration granted accelerated approval to tazemetostat (TAZVERIK™, Epizyme, Inc.), an EZH2 inhibitor, for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least 2 prior systemic therapies,…

A product-specific J-code for an mUC treatment is now available

• Amanda Bridges
• June 19, 2020
• Drugs
• No Comments

  We are pleased to announce the assignment of a product-specific, permanent J-code for PADCEV. The Centers for Medicare & Medicaid Services (CMS) released the July 2020 Quarterly Healthcare Common Procedural Coding System (HCPCS) File, which includes the designation of J9177 for PADCEV with the effective date of July 1, 2020.1 * Note that the product’s NDC code…

FDA approves gemtuzumab ozogamicin for CD33-positive AML in pediatric patients

• Amanda Bridges
• June 18, 2020
• Drugs
• No Comments

On June 16, 2020, the Food and Drug Administration extended the indication of gemtuzumab ozogamicin (MYLOTARGTM, Wyeth Pharmaceuticals LLC) for newly-diagnosed CD33-positive acute myeloid leukemia (AML) to include pediatric patients 1 month and older. Efficacy and safety in the pediatric population were supported by data from AAML0531 (NCT00372593), a multicenter randomized study of 1,063 patients…

FDA approves pembrolizumab for adults and children with TMB-H solid tumors

• Amanda Bridges
• June 18, 2020
• Drugs
• No Comments

Food and Drug Administration granted accelerated approval to pembrolizumab (KEYTRUDA, Merck & Co., Inc.) for the treatment of adult and pediatric patients with unresectable or metastatic tumor mutational burden-high (TMB H) [≥10 mutations/megabase (mut/Mb)] solid tumors, as determined by an FDA-approved test, that have progressed following prior treatment and who have no satisfactory alternative treatment…

Testing for Gaucher Disease

• Amanda Bridges
• June 18, 2020
• Drugs
• No Comments

Gaucher disease is a lifelong, progressive disease. Test to know. It’s a simple blood test. Learn more!

ENHERTU® (fam-trastuzumab deruxtecan-nxki)

• Amanda Bridges
• June 17, 2020
• Drugs
• No Comments

Effective July 1, 2020, ENHERTU® (fam-trastuzumab deruxtecan-nxki) will have a permanent j-code: J9358. ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2–based regimens in the metastatic setting.1 This indication is approved under accelerated…

Genentech is excited to share the news of the new FDA approved indication TECENTRIQ®

• Amanda Bridges
• June 16, 2020
• Drugs
• No Comments

Genentech is excited to share the news of the new FDA approved indication. TECENTRIQ® (atezolizumab), in combination with bevacizumab, is indicated for the first-line (1L) treatment of unresectable or metastatic hepatocellular carcinoma (HCC) treatment. Please see attached for additional information, as well as the TECENTRIQ and the Avastin full Prescribing Information, and Important Safety Information for…

FDA grants accelerated approval to lurbinectedin for metastatic small cell lung cancer

• Amanda Bridges
• June 16, 2020
• Drugs
• No Comments

On June 15, 2020, the Food and Drug Administration granted accelerated approval to lurbinectedin (ZEPZELCA, Pharma Mar S.A.) for adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy. Efficacy was demonstrated in the PM1183-B-005-14 trial (Study B-005; NCT02454972), a multicenter open-label, multi-cohort study enrolling 105 patients with…

FDA approves ramucirumab plus erlotinib for first-line metastatic NSCLC

• Amanda Bridges
• June 5, 2020
• Drugs
• No Comments

On May 29, 2020, the Food and Drug Administration approved ramucirumab (CYRAMZA®, Eli Lilly and Company) in combination with erlotinib for first-line treatment of metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) mutations. Efficacy was evaluated in RELAY (NCT02411448), a multinational, randomized, double-blind, placebo-controlled,…

FDA approves atezolizumab plus bevacizumab for unresectable hepatocellular carcinoma

• Amanda Bridges
• June 5, 2020
• Drugs
• No Comments

On May 29, 2020, the Food and Drug Administration approved atezolizumab in combination with bevacizumab (TECENTRIQ® and AVASTIN®, Genentech Inc.) for patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy. Efficacy was investigated in IMbrave150 (NCT03434379), a multicenter, international, open-label, randomized trial in patients with locally advanced unresectable or metastatic hepatocellular…

FDA approves nivolumab plus ipilimumab and chemotherapy for first-line treatment of metastatic NSCLC

• Amanda Bridges
• May 29, 2020
• Drugs
• No Comments

On May 26, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY, Bristol-Myers Squibb Co.) and 2 cycles of platinum-doublet chemotherapy as first-line treatment for patients with metastatic or recurrent non-small cell lung cancer (NSCLC), with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase…

FDA approves brigatinib for ALK-positive metastatic NSCLC

• Amanda Bridges
• May 26, 2020
• Drugs
• No Comments

On May 22, 2020, the Food and Drug Administration approved brigatinib (ALUNBRIG®, ARIAD Pharmaceuticals Inc.) for adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test. Today, the FDA also approved the Vysis ALK Break Apart FISH Probe Kit (Abbott Molecular, Inc.) as a companion diagnostic…

FDA approves ripretinib for advanced gastrointestinal stromal tumor

• Amanda Bridges
• May 20, 2020
• Drugs
• No Comments

On May 15, 2020, the Food and Drug Administration approved ripretinib (QINLOCK™, Deciphera Pharmaceuticals, LLC.), for adult patients with advanced gastrointestinal stromal tumor (GIST) who have received prior treatment with 3 or more kinase inhibitors, including imatinib. Efficacy was evaluated in INVICTUS (NCT03353753), an international, multi-center, randomized (2:1), double-blind, placebo-controlled trial in 129 patients with…

FDA grants accelerated approval to rucaparib for BRCA-mutated metastatic castration-resistant prostate cancer

• Amanda Bridges
• May 20, 2020
• Drugs
• No Comments

On May 15, 2020, the Food and Drug Administration granted accelerated approval to rucaparib (RUBRACA®, Clovis Oncology, Inc.) for patients with deleterious BRCA mutation (germline and/or somatic)-associated metastatic castration-resistant prostate cancer (mCRPC) who have been treated with androgen receptor-directed therapy and a taxane-based chemotherapy. Efficacy was investigated in TRITON2 (NCT02952534), an ongoing, multi-center, single arm clinical trial…

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

• Amanda Bridges
• May 20, 2020
• Drugs
• No Comments

On May 15, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO®, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY®, Bristol-Myers Squibb Co.) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma…

FDA grants accelerated approval to pomalidomide for Kaposi sarcoma

• Amanda Bridges
• May 20, 2020
• Drugs
• No Comments

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…

Now FDA-approved: QINLOCK™ (ripretinib)

• Amanda Bridges
• May 20, 2020
• Drugs
• No Comments

FDA approves olaparib for HRR gene-mutated metastatic castration-resistant prostate cancer

• Amanda Bridges
• May 20, 2020
• Drugs
• No Comments

On May 19, 2020, the Food and Drug Administration approved olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals, LP) for adult patients with deleterious or suspected deleterious germline or somatic homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC), who have progressed following prior treatment with enzalutamide or abiraterone. Today, the FDA also approved FoundationOne® CDx (Foundation Medicine, Inc.)…

FDA approves atezolizumab for first-line treatment of metastatic NSCLC with high PD-L1 expression

• Amanda Bridges
• May 19, 2020
• Drugs
• No Comments

On May 18, 2020, the Food and Drug Administration approved atezolizumab (TECENTRIQ®, Genentech Inc.) for the first-line treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression (PD-L1 stained ≥ 50% of tumor cells [TC ≥ 50%] or PD-L1 stained tumor-infiltrating immune cells [IC] covering ≥ 10% of…

FDA approves nivolumab plus ipilimumab for first-line mNSCLC (PD-L1 tumor expression ≥1%)

• Amanda Bridges
• May 15, 2020
• Drugs
• No Comments

On May 15, 2020, the Food and Drug Administration approved the combination of nivolumab (OPDIVO®, Bristol-Myers Squibb Co.) plus ipilimumab (YERVOY®, Bristol-Myers Squibb Co.) as first-line treatment for patients with metastatic non-small cell lung cancer whose tumors express PD-L1(≥1%), as determined by an FDA-approved test, with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma…

FDA approves selpercatinib for lung and thyroid cancers with RET gene mutations or fusions

• Katrina Williams
• May 11, 2020
• Drugs
• No Comments

On May 8, 2020, the Food and Drug Administration granted accelerated approval to selpercatinib (RETEVMOTM, Eli Lilly and Company) for the following indications: Adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC); Adult and pediatric patients ≥12 years of age with advanced or metastatic RET-mutant medullary thyroid cancer (MTC) who require systemic therapy;…

FDA expanded the indication of olaparib to include its combination with bevacizumab

• Katrina Williams
• May 11, 2020
• Drugs
• No Comments

Food and Drug Administration expanded the indication of olaparib (LYNPARZA®, AstraZeneca Pharmaceuticals, LP) to include its combination with bevacizumab for first-line maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination…

FDA grants accelerated approval to capmatinib for metastatic non-small cell lung cancer

• Amanda Bridges
• May 7, 2020
• Drugs
• No Comments

On May 6, 2020, the Food and Drug Administration granted accelerated approval to capmatinib (TABRECTATM, Novartis) for adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a mutation that leads to mesenchymal-epithelial transition (MET) exon 14 skipping as detected by an FDA-approved test. Today, FDA also approved the FoundationOne CDx assay (Foundation…

Bayer and NeoGenomics Launch the Test4TRKTM Program to Provide Genomic Cancer Testing at No Cost for People Living with Advanced Thyroid and Colorectal Cancers

• Amanda Bridges
• May 7, 2020
• Drugs
• No Comments

Bayer today announced the launch of Test4TRKTM program in collaboration with NeoGenomics, Inc. to offer genomic cancer testing for NTRK gene fusions at no cost for patients with RAI-refractory (RAI-R) differentiated thyroid carcinoma (DTC) and metastatic colorectal cancer (mCRC) with high microsatellite instability (MSI-H). NTRK gene fusions, which have been shown to drive tumor growth, are more commonly found in patients with MSI-H mCRC and RAI-R DTC and may play a role in disease management.

Pfizer announce first participants dosed in clinical trial program for a potential COVID19 Vaccine

• Amanda Bridges
• May 7, 2020
• Drugs
• No Comments

Pfizer Inc.and BioNTech SE has announced that the first participants have been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19. The trial is part of a global development program, and the dosing of the first cohort in Germany was completed last week. The Phase 1/2…

FDA approves daratumumab and hyaluronidase-fihj for multiple myeloma

• Amanda Bridges
• May 7, 2020
• Drugs
• No Comments

On May 1, 2020, the Food and Drug Administration approved daratumumab and hyaluronidase-fihj (DARZALEX FASPROTM, Janssen Biotech, Inc.) for adult patients with newly diagnosed or relapsed/refractory multiple myeloma. This new product allows for subcutaneous dosing of daratumumab. Daratumumab and hyaluronidase-fihj is approved for the following indications that intravenous daratumumab had previously received: in combination with…

U.S. Food and Drug Administration Approves DARZALEX FASPROTM (daratumumab and hyaluronidase-fihj), a New Subcutaneous Formulation of Daratumumab in the Treatment of Patients with Multiple Myeloma

• Amanda Bridges
• May 5, 2020
• Drugs
• No Comments

Janssen, a Johnson and Johnson pharmaceutical company, is happy to share some exciting news – The FDA just approved DARZALEX FASPRO, a new subcutaneous formulation approved in four regimens across five indications, including newly diagnosed, transplant-ineligible and relapsed or refractory multiple myeloma. As you may know, today’s news is based on results from the COLUMBA…

FDA approves niraparib for first-line maintenance of advanced ovarian cancer

• Amanda Bridges
• May 1, 2020
• Drugs
• No Comments

On April 29, 2020, the Food and Drug Administration approved niraparib (ZEJULA, GlaxoSmithKline) for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy. Efficacy was investigated in PRIMA (NCT02655016), a double-blind, placebo-controlled trial that randomized 733…

FDA approves new dosing regimen for pembrolizumab

• Amanda Bridges
• April 30, 2020
• Drugs
• No Comments

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…

FDA grants accelerated approval to pemigatinib for cholangiocarcinoma with an FGFR2 rearrangement or fusion

• Amanda Bridges
• April 24, 2020
• Drugs
• No Comments

On April 17, 2020, the Food and Drug Administration granted accelerated approval to pemigatinib (PEMAZYRE™, Incyte Corporation) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. The FDA also approved the FoundationOne® CDX…

Merck Sharp & Dohme Corp. (“Merck”), a subsidiary of Merck & Co., Inc., is pleased to announce that ONTRUZANT® (trastuzumab-dttb) for injection

• Amanda Bridges
• April 24, 2020
• Drugs
• No Comments

Merck Sharp & Dohme Corp. (“Merck”), a subsidiary of Merck & Co., Inc., is pleased to announce that ONTRUZANT® (trastuzumab-dttb) for injection, for intravenous use 21 mg/mL, a biosimilar* to Herceptin® (trastuzumab), is available through specialty distributors and wholesalers. Please contact your specialty distributor or wholesaler to confirm product availability. * Biosimilar means that the biological product is approved…

FDA grants accelerated approval to sacituzumab govitecan-hziy for metastatic triple negative breast cancer

• Amanda Bridges
• April 24, 2020
• Drugs
• No Comments

On April 22, 2020, the Food and Drug Administration granted accelerated approval to sacituzumab govitecan-hziy (TRODELVYTM, Immunomedics, Inc.) for adult patients with metastatic triple-negative breast cancer who received at least two prior therapies for metastatic disease. Efficacy was demonstrated in IMMU-132-01(NCT 01631552), a multicenter, single-arm, trial enrolling 108 patients with metastatic triple negative breast cancer…

FDA approves ibrutinib plus rituximab for chronic lymphocytic leukemia

• Amanda Bridges
• April 24, 2020
• Drugs
• No Comments

 On April 21, 2020, the Food and Drug Administration expanded the indication of ibrutinib (IMBRUVICA®, Pharmacyclics LLC) to include its combination with rituximab for the initial treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). This review was conducted under Project Orbis, an initiative of the FDA Oncology Center of Excellence….

Seagen: Introducing a New Treatment Regimen

• Amanda Bridges
• April 22, 2020
• Drugs
• No Comments

We are excited to announce the approval of TUKYSA by the U.S. Food and Drug Administration (FDA). TUKYSA is indicated in combination with trastuzumab and capecitabine for treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the…

NCCN released recommendations for the use of hematopoietic growth factors during the COVID-19 pandemic

• Katrina Williams
• April 16, 2020
• Drugs
• No Comments

In response to the COVID-19 pandemic, National Comprehensive Cancer Network® (NCCN®) has released recommendations for the use of hematopoietic growth factors during this time. The recommendations have been posted on NCCN’s website, along with other COVID-19 Resources: Hematopoietic Growth Factors Recommendations NCCN COVID-19 Resources NCCN noted that for acute myeloid leukemia (AML) and myelodysplastic syndromes…

FDA approved mitomycin (JELMYTO™, UroGen Pharma) for adult patients with low-grade upper tract urothelial cancer (LG-UTUC)

• Katrina Williams
• April 16, 2020
• Drugs
• No Comments

Food and Drug Administration approved mitomycin (JELMYTO™, UroGen Pharma) for adult patients with low-grade upper tract urothelial cancer (LG-UTUC). More Information. April 15, 2020 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-mitomycin-low-grade-upper-tract-urothelial-cancer  Hematology/Oncology (Cancer) Approvals & Safety Notifications    https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications

FDA approved selumetinib (KOSELUGO®, AstraZeneca) for pediatric patients

• Katrina Williams
• April 13, 2020
• Drugs
• No Comments

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…

Hematology/Oncology (Cancer) Approvals & Safety Notifications

• Amanda Bridges
• April 9, 2020
• Drugs
• No Comments

FDA does not issue approval announcements for every approval or drug label update that occurs in oncology and hematology. Please refer to Drugs@FDA for the latest approvals and prescribing information for specific products. 2020 Food and Drug Administration approved encorafenib (BRAFTOVI, Array BioPharma Inc.) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer…

FDA approves encorafenib in combination with cetuximab for metastatic colorectal cancer with a BRAF V600E mutation

• Amanda Bridges
• April 9, 2020
• Drugs
• No Comments

On April 8, 2020, the Food and Drug Administration approved encorafenib (BRAFTOVI, Array BioPharma Inc.) in combination with cetuximab for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, detected by an FDA-approved test, after prior therapy. Efficacy was evaluated in a randomized, active-controlled, open-label, multicenter trial (BEACON CRC;…

FDA approved luspatercept-aamt (REBLOZYL, Celgene Corporation) for the treatment of anemia

• Katrina Williams
• April 6, 2020
• Drugs
• No Comments

Food and Drug Administration approved luspatercept-aamt (REBLOZYL, Celgene Corporation) for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell (RBC) units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts (MDS-RS) or with myelodysplastic/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis…

Food and Drug Administration approved durvalumab (IMFINZI®, AstraZeneca) in combination with etoposide and either carboplatin or cisplatin as first-line treatment of patients with extensive-stage small cell lung cancer (ES-SCLC)

• Katrina Williams
• March 30, 2020
• Drugs
• No Comments

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…

FDA approval for Neratinib to Treat HER2-Positive Metastatic Breast Cancer

• Katrina Williams
• March 23, 2020
• Drugs
• No Comments

Great news!  Puma Biotechnology received U.S. FDA approval for Neratinib to Treat HER2-Positive Metastatic Breast Cancer.  The sNDA approval was based on results of the Phase III NALA trial, a randomized controlled trial of neratinib plus capecitabine in patients with HER2-positive metastatic breast cancer who have received two or more prior anti-HER2-based regimens. Adam M….

Taiho Oncology Announcement

• Katrina Williams
• February 12, 2020
• Drugs
• No Comments

On behalf of Taiho Oncology, Inc., we are pleased to inform you that a corporate press release, “Astex Pharmaceuticals announces U.S. Food and Drug Administration (FDA) acceptance for review of an NDA for the combination oral hypomethylating agent cedazuridine and decitabine (ASTX727 or oral C-DEC), for the treatment of MDS and CMML” has been issued…

FDA grants approval for TAZVERIK

• Katrina Williams
• January 29, 2020
• Drugs
• No Comments

Epizyme announces that U.S. Food and Drug Administration (FDA) has granted accelerated approval of TAZVERIK (tazemetostat) for the treatment of adults and pediatric patients age 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for resection, based on overall response rate and duration of response in a Phase 2 clinical trial.  You…

FDA approves Keytruda for treatment of patients with BCG

• Katrina Williams
• January 29, 2020
• Drugs
• No Comments

Merck is pleased to announce that KEYTRUDA® (pembrolizumab) has been approved by the FDA for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. PD-L1 diagnostic testing is not…

FDA approves first treatment option specifically for patients with epithelioid sarcoma, a rare soft tissue cancer

• Katrina Williams
• January 24, 2020
• Drugs
• No Comments

Today, the U.S. Food and Drug Administration granted accelerated approval to Tazverik (tazemetostat) for the treatment of adults and pediatric patients aged 16 years and older with metastatic (when cancer cells spread to other parts of the body) or locally advanced (when cancer has grown outside the organ it started in, but has not yet…

FDA approves new therapy to treat a rare mutation in patients with gastrointestinal stromal tumors

• Katrina Williams
• January 10, 2020
• Drugs
• No Comments

Today, the U.S. Food and Drug Administration approved Ayvakit (avapritinib) for the treatment of adults with unresectable (unable to be removed with surgery) or metastatic (when cancer cells spread to other parts of the body) gastrointestinal stromal tumor (GIST) – a type of tumor that occurs in the gastrointestinal tract, most commonly in the stomach…

FDA approved pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for the treatment of patients with Bacillus Calmette-Guerin (BCG)

• Katrina Williams
• January 8, 2020
• Drugs
• No Comments

Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck & Co. Inc.) for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. More Information. January 8, 2020 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-pembrolizumab-bcg-unresponsive-high-risk-non-muscle-invasive-bladder-cancer  Hematology/Oncology (Cancer)…

FDA grants approval to fam-trastuzumab deruxtecan-nxki (ENHERTU®)

• Katrina Williams
• December 23, 2019
• Drugs
• No Comments

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…

FDA approved enzalutamide (XTANDI, Astellas Pharma Inc.)

• Katrina Williams
• December 17, 2019
• Drugs
• No Comments

FDA approved enzalutamide (XTANDI, Astellas Pharma Inc.) for patients with metastatic castration-sensitive prostate cancer (mCSPC). More Information. December 16, 2019 https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-enzalutamide-metastatic-castration-sensitive-prostate-cancer  Hematology/Oncology (Cancer) Approvals & Safety Notifications    https://www.fda.gov/drugs/resources-information-approved-drugs/hematologyoncology-cancer-approvals-safety-notifications  

Info on accelerated approval for BRUKINSA

• Katrina Williams
• December 11, 2019
• Drugs
• No Comments

Please be aware NCCN has recently updated their Oncology Guidelines for Mantel Cell Leukemia (MCL) based on the accelerated approval for BRUKINSA. NCCN has provided BRUKINSA (zanubrutinib) in R/R MCL with a Level 2A Preferred evidence listing, comparable to other BTKi in the class. This is the link to the NCCN main website, https://www.nccn.org/professionals/physician_gls/default.aspx . 

CALQUENCE® (acalabrutinib) Receives US FDA Approval for New Indication

• Amanda Bridges
• December 3, 2019
• Drugs
• No Comments

The US Food and Drug Administration (FDA) has approved CALQUENCE® (acalabrutinib) capsules for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CALQUENCE for CLL was granted Breakthrough Therapy Designation by the FDA, and the approval was granted under the FDA’s Real Time Oncology Review (RTOR) and newly established…

Introducing BRUKINSA™ (zanubrutinib)—the new BTK inhibitor

• Amanda Bridges
• November 18, 2019
• Drugs
• No Comments

FDA approves therapy to treat patients with relapsed and refractory mantle cell lymphoma supported by clinical trial results showing high response rate of tumor shrinkage For Immediate Release: November 14, 2019 Today, the U.S. Food and Drug Administration granted accelerated approval to Brukinsa (zanubrutinib) capsules for the treatment of adult patients with mantle cell lymphoma…

FDA Approved REBLOZYL® (luspatercept-aamt)

• Katrina Williams
• November 15, 2019
• Drugs
• No Comments

The US Food and Drug Administration has recently approved REBLOZYL® (luspatercept-aamt), the first and only erythroid maturation agent (EMA) indicated for the treatment of anemia in adult patients with beta thalassemia who require regular red blood cell (RBC) transfusions. REBLOZYL is not indicated for use as a substitute for RBC transfusions in patients who require…

Alexion Receives FDA Approval For ULTOMIRIS® (Ravulizumab-Cwvz) For Atypical Hemolytic Uremic Syndrome (AHUS)

• Katrina Williams
• November 3, 2019
• Drugs
• No Comments

October 18, 2019 at 7:45 PM EDT PDF Version – At 26 weeks, 54% of adults and 71% of children treated with ULTOMIRIS demonstrated Complete Thrombotic Microangiopathy (TMA) Response – BOSTON–(BUSINESS WIRE)–Oct. 18, 2019– Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced that the U.S. Food and Drug Administration (FDA) approved ULTOMIRIS® (ravulizumab-cwvz) for the treatment of atypical hemolytic uremic syndrome (aHUS)…

CMS coverage changes regarding CAR T Therapies

• Katrina Williams
• September 3, 2019
• Drugs
• No Comments

Recently, the Centers for Medicare and Medicaid Services (CMS) posted two announcements which impacts payment and coverage  for Chimeric Antigen Receptor T-Cell (CAR T) Therapies.  This email will provide a brief summary of the Fiscal Year (FY) 2020 Inpatient Prospective Payment System (IPPS) Final Rule, and the National Coverage Determination (NCD) for CAR T cell therapy…

Approval of a new product for myelofibrosis

• Amanda Bridges
• August 22, 2019
• Drugs
• No Comments

Celgene is pleased to inform you of the US Food and Drug Administration’s recent approval of INREBIC® (fedratinib) capsules, a product from Celgene indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF). Attached please find an announcement of this recent approval. http://cloud.info-celgene.com/inrebicpro INDICATION…

Announcing a New Genentech Therapy for ROS1+ mNSCLC and NTRK+ Solid Tumors

• Amanda Bridges
• August 22, 2019
• Drugs
• No Comments

Dear Healthcare Professional:  Genentech is excited to share the news of a new FDA approval. ROZLYTREK™ (entrectinib) is now FDA approved for the treatment of adult patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive. ROZLYTREK is also FDA approved for the treatment of adult and pediatric patients 12 years of age…

FDA Approves First Therapy for Rare Joint Tumor

• FLASCO
• August 5, 2019
• Drugs
• No Comments

The U.S. Food and Drug Administration granted approval to Turalio (pexidartinib) capsules for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not responsive to improvement with surgery.   “TGCT can cause debilitating symptoms for patients such as pain, stiffness and limitation of movement….

FDA approves pembrolizumab for advanced esophageal squamous cell cancer

• FLASCO
• July 31, 2019
• Drugs
• No Comments

On July 30, 2019, the Food and Drug Administration approved pembrolizumab (KEYTRUDA, Merck) for patients with recurrent, locally advanced or metastatic, squamous cell carcinoma of the esophagus (ESCC) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥10), as determined by an FDA-approved test, with disease progression after one or more prior lines of systemic therapy….

FDA approves darolutamide for non-metastatic castration-resistant prostate cancer

• FLASCO
• July 31, 2019
• Drugs
• No Comments

On July 30, 2019, the Food and Drug Administration approved darolutamide (NUBEQA, Bayer HealthCare Pharmaceuticals Inc.) for non-metastatic castration-resistant prostate cancer. Approval was based on ARAMIS (NCT02200614), a multicenter, double-blind, placebo-controlled clinical trial in 1,509 patients with non-metastatic castration resistant prostate cancer. Patients were randomized (2:1) to receive either 600 mg darolutamide orally twice daily (n=955)…

FDA approves Ruxience (rituximab-pvvr), biosimilar to Rituxan (rituximab)

• FLASCO
• July 24, 2019
• Drugs
• No Comments

The U.S Food and Drug Administration (FDA) today approved Ruxience (rituximab-pvvr), a biosimilar to U.S.-licensed Rituxan (rituximab) for the treatment of adult patients with CD20-positive B-cell non-Hodgkin’s lymphoma (NHL) to be used as a single agent or in combination with chemotherapy, and CD20-positive Chronic Lymphocytic Leukemia (CLL) in combination with chemotherapy. Ruxience is also the…

FDA grants accelerated approval to selinexor for multiple myeloma

• FLASCO
• July 10, 2019
• Drugs
• No Comments

On July 3, 2019, the Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents,…

FDA approves selinexor for multiple myeloma

• FLASCO
• July 3, 2019
• Drugs
• No Comments

On July 3, 2019, the Food and Drug Administration granted accelerated approval to selinexor (XPOVIO, Karyopharm Therapeutics) in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents,…

Change to the Herceptin HYLECTA™ (trastuzumab and hyaluronidase-oysk) J-code

• Katrina Williams
• July 3, 2019
• Drugs
• No Comments

Centers for Medicare & Medicaid Services (CMS) has made a change to the Herceptin HYLECTA™ (trastuzumab and hyaluronidase-oysk) J-code and has assigned a permanent J-code.  Effective July 1, 2019 the permanent J-code for Herceptin HYLECTA is J9356. If you have any questions, please reach out to me directly. You may also call Genentech Access Solutions at…

KEYTRUDA(R) (pembrolizumab): Additional Indication

• FLASCO
• July 2, 2019
• Drugs
• No Comments

Merck is pleased to announce that KEYTRUDA has been approved by the FDA for the treatment of patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy and at least 1 other prior line of therapy. This indication is approved under accelerated approval based on tumor response rate and…

FDA approves Zirabev (bevacizumab-bvzr), a biosimilar to Avastin (bevacizumab)

• FLASCO
• July 2, 2019
• Drugs
• No Comments

FDA approves Zirabev (bevacizumab-bvzr), a biosimilar to U.S.-licensed Avastin (bevacizumab).   A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an already-FDA approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms…

Recent update to the TECENTRIQ (atezolizumab) Prescribing Information

• Katrina Williams
• July 2, 2019
• Drugs
• No Comments

There was a recent update to the TECENTRIQ (atezolizumab) Prescribing Information that impacted the dosing regimens for certain indications. This change would allow for either the 840 mg or 1200 mg vials to be used for those indications. Please see below for the NDC information. Updated Prescribing Information Urothelial Carcinoma o   Administer TECENTRIQ as: 840…

FDA approves daratumumab for multiple myeloma ineligible for autologous stem cell transplant

• FLASCO
• June 28, 2019
• Drugs
• No Comments

On June 27, 2019, the Food and Drug Administration approved daratumumab (DARZALEX®, Janssen Biotech, Inc.) in combination with lenalidomide and dexamethasone for patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. Approval was based on MAIA (NCT02252172), an open-label, randomized (1:1), active-controlled phase 3 study, comparing dartumumab (16 mg/kg) in…

FDA Approves Amgen And Allergan’s KANJINTI™ (trastuzumab-anns),

• FLASCO
• June 19, 2019
• Drugs
• No Comments

Amgen (NASDAQ:AMGN) and Allergan plc (NYSE:AGN) announced that the U.S. Food and Drug Administration (FDA) has approved KANJINTI™ (trastuzumab-anns) for all approved indications of the reference product, Herceptin® (trastuzumab):  for the treatment of HER2-overexpressing adjuvant and metastatic breast cancer and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma. “The FDA approval of KANJINTI is an important milestone for our biosimilars portfolio, providing an additional treatment…