Fda grants orphan drug exclusivity to evomela melphalan for. Highlights of prescribing information limitation of. Fda approves new multiple myeloma drug, ninlaro blackdoctor. Fda approves daratumumab for multiple myeloma ineligible. Food and drug administration fda has just approved a drug called darzalex daratumumab in combination with the drug velcade bortezomib, melphalan, and prednisone. Most impressive was the us food and drug administration fda approval of 4 novel agentspanobinostat farydak. Mar 16, 2016 the us food and drug administration fda has granted approval for captisolenabled melphalan evomela, spectrum for two indications in multiple myeloma one indication is for use as a highdose. Dose modification guidelines, as summarized in table 1 below, are recommended to manage grade 3 or 4 neutropenia or thrombocytopenia or other grade 3 or 4 toxicity judged to be related to revlimid.
Lenalidomide is indicated for the treatment of multiple myeloma in. Fda helps streamline approval process for supplemental drug. Celgene will market revlimid for use in combination with the steroid. Mm occurs slightly more often in men than in women, and it is twice as common in african american persons compared with white persons. Multiple myeloma mm or plasma cell myeloma, is a cancer of plasma cells, a type of white blood cell normally responsible for producing antibodies. Lenalidomide approved as firstline therapy in multiple myeloma. Daratumumab was previously granted accelerated approval in november 2015 as monotherapy for patients with multiple myeloma who have received at least three prior lines of therapy, including a. Drugs approved for multiple myeloma and other plasma cell neoplasms. Food and drug administration as a possible treatment of multiple myeloma, sellas. Multiple myeloma drugs market and forecast 20202025. Data in this post comes from camargos proprietary 505b2 database, and from fdas public databases including the orange book. Risk factors include obesity, radiation exposure, family. And most multiple myeloma patients were moved from thalomid to revlimid. Fda approves new immunotherapy treatment for multiple myeloma.
Janssens investigational multiple myeloma drug daratumumab has been granted breakthrough therapy designation by the us fda. Celgene will market revlimid for use in combination with the steroid dexamethasone in patients with multiple myeloma who have been treated with chemotherapy. Fda approval for use with dexamethasone in patients with multiple. This status does not guarantee approval for the human cd38 monoclonal antibody but, like the fda s longestablished fasttrack programme, it should speed up the process. Developed by kite pharma, yescarta was approved for patients with nonhodgkins lymphoma who have failed at least two lines of therapy.
Food and drug administration fda for the treatment of multiple myeloma, according to active biotech. On september 26, 2019, the food and drug administration approved daratumumab darzalex, janssen for adult patients with multiple. The food and drug administration fda recently released a statement providing data from the two phase 3 trials testing keytruda pembrolizumab in patients with multiple myeloma. Fda places keytruda multiple myeloma studies on hold the. Fda approval in myeloma, breakthrough designations in rcc and. On july 3, 2019, the food and drug administration granted accelerated approval to selinexor xpovio, karyopharm therapeutics in. Gina columbus reports on an fda approval in multiple myeloma, breakthrough therapy designations in renal cell carcinoma and aplastic anemia, promising results in a melanoma trial, and a japanese. Nov 08, 2016 fda puts brakes on multiple myeloma study november 8, 2016 swedish company bioinvent international has received verbal notice from the fda that a full clinical hold i. Food and drug administration had placed a clinical hold on three multiple myeloma studies testing its keytruda in combination with other medicines for the blood. Tasquinimod has been developed primarily for the treatment of prostate cancer, but its. Drugs approved for multiple myeloma national cancer. These two recent fda approvals increases our optimism for accelerated car t cell therapy approvals in myeloma, said jenny ahlstrom, founder of the myeloma crowd and a myeloma patient for. Karyopharm therapeutics in combination with dexamethasone for adult patients with relapsed or refractory multiple myeloma rrmm who.
On september 26, 2019, the food and drug administration approved daratumumab darzalex, janssen for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and. The list includes generic names, brand names, and common drug combinations, which are shown in capital letters. Fda says janssens myeloma drug is a breakthrough therapy. The trials were using the companys checkpoint inhibitor nivolumab opdivo to treat patients with relapsed or refractory multiple myeloma. Symptoms include a weakened immune system and bone and kidney problems. The myeloma crowd research initiative mcri helps fund an innovative car t cell research program for myeloma at the university of wurzburg in germany.
On september 7, celgene announced that six of its trials in partnership with astrazeneca were placed on full or partial holds by the fda. May 14, 2018 the investigational cancer vaccine galinpepimuts gps has been designated an orphan drug by the u. Fda approves daratumumab for transplanteligible multiple. Deaths were reported in studies combining the new drug when used with celgenes immunomodulators lenalidomide and pomalidomide. The food and drug administration fda has approved three new drugs for the treatment of multiple myeloma that has returned after prior therapy on november 16, the fda approved daratumumab darzalex for patients who have previously received at least three prior treatments. Nov 16, 2015 fda approves drug for multiple myeloma patients resistant to other drugs darzalex reduced tumors in patients who had become resistant to at least three other treatments. Revlimid lenalidomide was granted approval by the food and drug administration fda as a maintenance therapy for patients with multiple myeloma who have had autologous hematopoietic stem cell transplant autohsct, according to celgene, the manufacturer of the treatment. Gina columbus reports on an fda approval in multiple myeloma, breakthrough therapy designations in renal cell carcinoma and aplastic anemia, promising results in a melanoma trial, and a.
The food and drug administration fda has approved two new uses for the drug daratumumab darzalex in patients with multiple myeloma. Fda approves new use for daratumumab in multiple myeloma. Fda approved multiple myeloma drugs intl myeloma fdn. Celgenes patent fortress protects revlimid, thalomid. It is synonymous with myeloma and plasma cell myeloma. Three new therapies approved for multiple myeloma national.
Revlimid lenalidomide was granted approval by the food and drug administration fda as a maintenance therapy for patients with multiple myeloma who have had autologous hematopoietic. Multiple myeloma is a type of cancer that forms in infectionfighting white blood cells produced in bone marrow. Fda puts brakes on multiple myeloma study november 8, 2016 swedish company bioinvent international has received verbal notice from the fda that a full clinical hold i. The us food and drug administration fda has granted approval for captisolenabled melphalan evomela, spectrum for two indications in multiple myeloma one indication is for use as a. Fda approves daratumumab for multiple myeloma ineligible for autologous stem cell transplant. Plasma cells make antibodies against infectious agents such as viruses and. Celgenes trials were using the checkpoint inhibitor. Fda approves new therapy for patients with previously treated. Food and drug administration had placed a clinical hold on three multiple myeloma studies testing its keytruda in combination with other medicines for the blood cancer after more deaths were reported in patients receiving the merck immunotherapy. From which fda division approved them, to who brought them to market, download our sponsor insights infographic and take a deeper dive into the 64 505b2 nda approvals of 2019. Electronic orange bookapproved drug products with therapeutic. Nov 30, 2015 oncologyhematology myeloma fda approves second antibody for myeloma pivotal trial showed significant gain in pfs with elotuzumab.
The fda has approved celgenes anemia drug revlimid lenalidomide as a treatment for multiple myeloma. Fda approves drug for multiple myeloma patients resistant to other drugs darzalex reduced tumors in patients who had become resistant to at least three other treatments. The us food and drug administration fda has approved the third drug this year for treating multiple myeloma, a type of cancer that starts in plasma cells. Fda approves second antibody for myeloma medpage today. Plasma cells make antibodies against infectious agents such as viruses and bacteria. Multiple myeloma mm accounts for approximately 1% of all cancers and 10% of all hematologic malignant disorders. Evomela has also been recently listed in the orange book, including two. The investigational cancer vaccine galinpepimuts gps has been designated an orphan drug by the u.
The food and drug administration fda has approved three new drugs for the treatment of multiple myeloma that has returned after prior therapy on november 16, the fda approved daratumumab. Fda approved daratumumab darzalex, janssen for adult patients with multiple myeloma in combination with bortezomib, thalidomide, and dexamethasone in. On november 16, the fda approved daratumumab darzalex for patients who have previously received at least three prior treatments. Celgene, expanding its use, in combination with lowdose dexamethasone, for the firstline treatment of patients with newly diagnosed multiple myeloma. Multiple myeloma is a cancer of the bone marrow plasma cells. On february 18, 2015, the us food and drug administration fda approved a new indication for lenalidomide revlimid. Ninlaro ixazomib is a targeted therapy drug approved to be given in combination with two other drugs lenalidomide and dexamethasone. This status does not guarantee approval for the human cd38 monoclonal. Oncologyhematology myeloma fda approves second antibody for myeloma pivotal trial showed significant gain in pfs with elotuzumab. Fda puts brakes on multiple myeloma study managed care. Fda grants accelerated approval to selinexor for multiple. The small molecule immunomodulatory drug tasquinimod has been designated an orphan drug by the u.
Fda approves new immunotherapy treatment for multiple myeloma by admin at 7 jan 2016, 12. Highlights of prescribing information limitation of use. Stacy simon november 17, 2015 the us food and drug administration fda has approved the first monoclonal antibody to treat people with multiple myeloma, a type of cancer that starts in plasma cells. Food and drug administration fda has expanded the officially approved use of revlimid to include the treatment of newly diagnosed multiple myeloma. Drugs approved for multiple myeloma national cancer institute. Maintenance revlimid gains fda approval for multiple myeloma. Further fda clinical trial holds intl myeloma fndn. Food and drug administration as a possible treatment of multiple myeloma, sellas life sciences announced. Treatment of patients with multiple myeloma with a pd1 or pdl1 blocking antibody in combination with a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials. Multiple myeloma drug tasquinimod granted fda orphan drug. Nov 20, 2015 the us food and drug administration fda has approved the third drug this year for treating multiple myeloma, a type of cancer that starts in plasma cells.
Most impressive was the us food and drug administration fda approval of 4 novel agentspanobinostat farydak, daratumumab darzalex, elotuzumab empliciti, and ixazomib ninlaroas well as new indications for 3 drugs already on the marketlenalidomide revlimid, carfilzomib kyprolis, and pomalidomide. Evomela was approved by fda based on its bioequivalence to the. Fda approves daratumumab for multiple myeloma ineligible for. Food and drug administration fda for the treatment of multiple myeloma, according. Second antibody fdaapproved against multiple myeloma. Just two weeks after the fda approved the first immunotherapy drug to treat multiple. Fda approves darzalex daratumumab for multiple myeloma written by. Food and drug administration fda has been making efforts over the past several years to expedite drug approvals. The fda orange book, prescribing labels, clinicaltrials. On june 27, 2019, the food and drug administration approved daratumumab darzalex, janssen biotech, inc. Celgene has 27 patents for revlimid listed in the fdas orange book. Fda approved daratumumab darzalex, janssen biotech, inc. The multiple myeloma research foundation mmrf praises the food and drug administrations fda decision to approve farydak panobinostat for patients with advanced myeloma and treatment. Velcade was approved under nda 021602 in 2003 and is the listed drug.
The year 2015 brought important advances in the treatment of multiple myeloma. Fda approves darzalex daratumumab for multiple myeloma. Fda grants accelerated approval to selinexor for multiple myeloma. Specifically, farydak is approved in combination with velcade bortezomib and dexamethasone for the treatment of multiple myeloma for patients who have received at least two. Multiple myeloma drugs fall into various drug classes, including proteasome inhibitors pis, immunomodulatory drugs imids, alkylating agents, corticosteriods, histone deactylase inhibitors hdacs, bisphophonates, and monoclonal antibodies mabs. The drug names link to ncis cancer drug information summaries. Jul 07, 2006 the fda has approved celgenes anemia drug revlimid lenalidomide as a treatment for multiple myeloma.
This list of current fdaapproved multiple myeloma drugs is organized by drug class, with a guide to the generic and brand names for each medication. Possible cancer vaccine for multiple myeloma named orphan. Multiple myeloma drug tasquinimod granted fda orphan drug status. Surprisingly, we found that no such chemical library of approved and clinical trial drugs is. Multiple myeloma is a systemic malignancy of plasma cells that accumulate. Evaluations orange book and, when associated with an innovator drug with current. The multiple myeloma research foundation mmrf praises the food and drug administrations fda decision to approve farydak panobinostat for patients with advanced myeloma and treatment resistant multiple myeloma. Food and drug administration fda has just approved a drug called darzalex daratumumab in combination with the drug velcade bortezomib, melphalan, and prednisone known collectively as vmp for patients who have been recently diagnosed with multiple myeloma but are not eligible for autologous stem cell transplant, reports cnbc. Delcath uses a proprietary system they call the percutaneous hepatic perfusion php system to deliver high doses of existing. A novel option is now available for patients with multiple myeloma who have tried at least three other drug therapies.
Orange book any patents issued after the fda approved the nda within thirty days. This page lists cancer drugs approved by the food and drug administration fda for multiple myeloma and other plasma cell neoplasms. The multiple myeloma research foundation commends the u. Fda oks drug for multiple myeloma patients resistant to. The trials were placed on clinical holds by the fda in july, after concerns arose regarding the drugs safety in this group of patients. Fda approves daratumumab for transplanteligible multiple myeloma. While there is no cure for multiple myeloma, sarclisa is now another cd38directed treatment option added to the list of fdaapproved. The list includes generic names, brand names, and common drug. The fda has approved pomalidomide for oral administration in the treatment of multiple myeloma in patients who have received at least 2 prior therapies, including lenalidomide and bortezomib, without response to treatment and with disease progression within 60 days of the last treatment. Advise females of reproductive potential of the potential risk to a fetus. Daratumumab was originally approved by the fda in november 2015 as a standalone treatment for patients whose cancer has progressed after receiving. Fda puts brakes on multiple myeloma study managed care magazine. Yescarta, a car t cell therapy, was approved by the food and drug administration fda on october 18, 2017, less than two months after the first gene therapy for a blood cancer came to market.
The b2 committee noted that there are two unexpired exclusivities listed in the orange book. The food and drug administration fda has approved three new drugs for the treatment of multiple myeloma that has returned after prior therapy. Nov 17, 2015 fda approves darzalex daratumumab for multiple myeloma written by. Just two weeks after the fda approved the first immunotherapy drug to treat multiple myeloma, a second immunotherapy drug, elotuzumab empliciti, received approval yesterday to treat resistant forms of multiple myeloma in combination with other therapies. A cancerous or malignant plasma cell is called a myeloma cell. Stacy simon november 17, 2015 the us food and drug administration fda has approved the first monoclonal.
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