Regulatory Update
The FDA approved tisotumab vedotin (Tivdak, Seagen and Genmab), on 9/20/2021, for the treatment of recurrent or metastatic cervical cancer with disease progression on or after chemotherapy. The prescribing information for tisotumab includes a BOXED WARNING for ocular toxicity, and Warnings for peripheral neuropathy, hemorrhage, pneumonitis, and embryo-fetal toxicity. The FDA granted ficlatuzumab a fast-track designation as a treatment for relapsed or recurrent head and neck squamous cell carcinoma. The FDA granted lanifibranor a fast-track designation as a treatment for non-alcoholic steatohepatitis with compensated cirrhosis. Announced Research Updates Pfizer and Lilly announced that in a 24-week, 145 patient, Phase III trial, patients treated with tanezumab had a 3.03 point decrease in their pain intensity score at eight-weeks compared to a 1.25 point decrease with placebo in patients with cancer that had metastasized to the bone or multiple myeloma, who were receiving optimized opioids. However, the difference in pain scores was not significant after eight weeks. Astellas announced that in the 12-week, 501 patient, Phase III, SKYLIGHT 2 trials, patients treated with fezolinetant reduced the severity of moderate to severe vasomotor symptoms (VMS) by 0.15 points at 4 weeks and 0.16 points at 12 weeks with 30 mg and 0.29 points at 4 weeks and 12 weeks with 45 mg compared to placebo in patients with moderate to severe VMS. The frequency of moderate to severe VMS events per day versus placebo was reduced by 1.82 events at 4 weeks and 1.86 events at 12 weeks with 30 mg and 2.55 events and 2.53 events with 45 mg compared to placebo Novan announced that in the 12-week, 891 patient, Phase III, B-SIMPLE4 trial, 32.5% of patients treated with SB206 achieved complete clearance of all treatable molluscum lesions compared to 19.7% with placebo in patients with molluscum contagiosum. Biohaven announced that in a 48-week, 336 patient, Phase III trial, treatment with verdiperstat did not improve the Unified Multiple System Atrophy Rating Scale compared to placebo in patients with Multiple System Atrophy. Published Research Updates In a 24-week, 118 patient, Phase II, open label trial, treatment with pemafibrate did not decrease the magnetic resonance imaging-estimated proton density fat fraction at 24-weeks, but did decrease MRE-based liver stiffness at 72-weeks compared to placebo in patients with high-risk, non-alcoholic fatty liver disease. In the 12-week, 496 patient, Phase III REFALS trial, treatment with levosimendan did not improve the slow vital capacity in the supine position compared to placebo in patients with ALS. In a seven-day, 16 patient, cross-over, Phase II trial, 81% of patients treated with reboxetine had a least a 50% reduction in apnea-hypopnea index compared to 13% with placebo in patients with obstructive sleep apnea. In the 104-week, 836 patient, open-label, Phase III, PYRENEES trial, roxadustat was non-inferior to erythropoiesis-stimulating agent (epoetin alfa or darbepoetin alfa) for changes in hemoglobin at weeks 36 and 52 in CKD patients on dialysis. In a 378 patient, Phase II trial, where treatment with tebentafusp resulted in overall survival of 73% compared to 59% with investigator choice of pembrolizumab, ipilimumab, or dacarbazine in patients with previously untreated HLA-A*02:01–positive patients with metastatic uveal melanoma. Our mission at Prescribe Right is to offer budget-friendly products that provide the information you need to proactively plan for budget-busting drugs. To commemorate our 100th COVID-19 update we are offering access to the knowledgebase for 100 hours or 100 days whichever comes first, for only $100. This offer expires at 11:59 pm on Friday, September 24, 2021.
Regulatory Update The FDA approved mobocertinib (Exkivity, Takeda), on 9/14/2021, for the treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations. Patients should be identified through an approved lab test. Mobocertinib Prescribing Information was approved with a boxed warning for QTc prolongation and Torsades de Pointes, and warnings and precautions for interstitial lung disease/pneumonitis, cardiac toxicity, and diarrhea.
The EMA recommended rejecting tanezumab for the treatment of pain associated with osteoarthritis. Announced Research Updates Zymeworks announced that in a 36 patient, Phase II trial, adding zanidatamab to capecitabine/oxaliplatin, 5FU/cisplatin 5FU/leucovorin/oxaliplatin resulted in an objective response rate of 75% in patients with metastatic HER2-positive gastroesophageal adenocarcinoma. Ampio announced that in the 12-week, 1,034 patient, Phase III, AP-013 trial, treatment with LMWF5A decreased the WOMAC pain and function scores compared to placebo in patients with severe osteoarthritis of the knee. Biogen announced that in the 12-week, 265 patient, Phase II, CONVEY trial, vixotrigine did not decrease the average daily pain score compared to placebo in patients with idiopathic or diabetes mellitus-associated small fiber neuropathy. EQRx announced interim data from the Phase III GEMSTONE-301 trial, where patients treated with sugemalimab achieved progression-free survival of 9 months compared to 5.8 months with placebo in Chinese patients with locally advanced/unresectable Stage III NSCLC without disease progression after concurrent or sequential chemoradiotherapy. Agenus announced that in a 155 patient, Phase II trial, treatment with balstilimab and zalifrelimab resulted in a 26% objective response rate (ORR) in patients with recurrent/metastatic cervical cancer. Coherus BioSciences and Junshi Biosciences announced interim results from the 514 patient, Phase III JUPITER-06 trial, where adding toripalimab to paclitaxel/cisplatin resulted in PFS of 5.7 months and overall survival of 17 months compared to 5.5 months and 11 months with paclitaxel/cisplatin alone in patients with advanced esophageal squamous cell carcinoma. Published Research Updates In the 596 patient, Phase II, ESCORT-1st trial, treatment with camrelizumab added to paclitaxel and cisplatin resulted in overall survival of 15.3 months and progression-free survival of 6.9 months compared to 12 months and 5.6 months with paclitaxel and cisplatin alone in Chinese patients with untreated advanced or metastatic esophageal squamous cell carcinoma. In a 60-week, 40 patient Phase I trial, GLS-5700 produced antibodies in all patients and 62% developed neutralizing antibodies. 70% of patients achieved 90% inhibition of Zika. Mice were injected with serum from the trial participants and 92% survived a potentially lethal injection of Zika In a draft analysis, ICER found tezepelumab to reduce the annualized asthma exacerbation rate compared to non-biologic standard of care in patients with severe, uncontrolled asthma. In patients with eosinophilic and non-eosinophilic asthma, the benefit was smaller than what is considered clinically important. ICER found tezepelumab to be comparable to dupilumab in patients with eosinophilic asthma, but insufficient evidence to compare tezepelumab to omalizumab in patients with allergic asthma. Using a placeholder annual cost of $28,000 ICER estimated the cost per QALY was $430,000 with tezepelumab. Regulatory Update
The FDA accepted the BLA for tislelizumab to treat unresectable recurrent locally advanced or metastatic esophageal squamous cell carcinoma and set a PDUFA date for 7/12/22. Announced Research Updates Sanofi announced that in the 37 week, 131 patient, Phase III, PEGASUS trial, treatment with rilzabrutinib did not increase the remission rate compared to placebo in patients with moderate-to-severe pemphigus. AstraZeneca announced that in the 1,013 patient, Phase III, open-label, POSEIDON trial, patients treated with durvalumab, tremelimumab and platinum-based chemotherapy achieved OS of 14 months and PFS of 6.2 months compared to 11.7 months and 4.8 months with platinum-based chemotherapy alone in patients with metastatic non-squamous or squamous non-small cell lung cancer without epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma kinase (ALK) fusions. Lilly announced that in the BRUIN trial, treatment with pirtobrutinib resulted in an overall response rate of 52% in 61 MCL patients and 63% in 139 chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) patients. AB Science announced that in the 60-month, 712 patient, Phase III, AB12003 trial, treatment with masitinib plus docetaxel did not improve progression free survival (PFS) compared to docetaxel alone in the overall population of patients with metastatic Castrate Refractory Prostate Cancer. PFS was increased with masitinib plus docetaxel in patients with an ALP of 250 IU/mL or <. Published Research Updates In a three-year, 6,861 patient, Phase III trial, three doses of RTS,S/AS01 in the first year, followed by a booster dose in year two and three resulted in 278 cases of malaria per 1000 person-years compared to 305 cases per 1000 person-years with sulphadoxine/pyrimethamine plus amodiaquine chemoprevention and 113 cases per 1000 person-years with the combination of vaccine and chemoprevention in children 5 to 17 months of age in sub-Saharan Africa. J&J is discontinuing the 2,637 patient, Phase IIb, Imbokodo trial, when the primary analysis failed to find a reduction in the incidence of HIV infection with the J&J HIV vaccine in a population of young women in sub-Saharan Africa at high risk of acquiring HIV. HHS amended the Public Readiness and Emergency Preparedness (PREP) Act to allow pharmacists to order and administer select therapeutics given orally, subcutaneously, or intramuscularly, including current and future medications that are approved, authorized, cleared, or licensed to treat or prevent COVID-19. This includes subcutaneous monoclonal antibodies. Licensed pharmacists, licensed or registered pharmacy interns, and qualified pharmacy technicians who meet the criteria in the amendment are also authorized to administer certain COVID-19 therapeutics. To be eligible an ACPE continuing education program must be completed and you must have current certification in CPR.
Regulatory Update
Shanghai Junshi Biosciences submitted a BLA for toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma. The FDA placed a clinical hold on the Phearless Phase 1/2 study which is evaluating BMN 307 as a treatment for phenylketonuria (PKU). The hold was due to safety findings in a pre-clinical pharmacology study. Announced Research Updates J&J is discontinuing the 2,637 patient, Phase IIb, Imbokodo trial, when the primary analysis failed to find a reduction in the incidence of HIV infection with the J&J HIV vaccine in a population of young women in sub-Saharan Africa at high risk of acquiring HIV. Takeda announced that in the 502 patient, Phase III, PANTHER trial, adding pevonedistat to azactidine did not improve event-free survival compared to azactidine alone in patients with higher-risk myelodysplastic syndromes, chronic myelomonocytic leukemia or low-blast acute myeloid leukemia. |
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