October 2021 • PharmaTimes Magazine • 8-9 

// HOT OR NOT //


HOT & NOT

NICE has recommended Janssen’s Erleada (apalutamide) for the treatment of prostate cancer, after previously rejecting the therapy. Previously, NICE published draft guidance rejecting Erleada combined with androgen deprivation therapy (ADT) for patients with hormone-relapsed prostate cancer who are at high risk of the cancer spreading (nmHRPC), or hormone-sensitive prostate cancer that has already metastasised (mHSPC). After reconsidering the evidence, NICE has recommended Erleada for the two indications within its marketing authorisation.


Bristol Myers Squibb’s (BMS) Opdivo (nivolumab) has been recommended by NICE for routine use on the NHS as a treatment for metastatic and recurrent head and neck cancer. New evidence collected from the CDF suggests that people who receive Opdivo are likely to live up to nine months longer than those with other treatments. NICE concluded that Opdivo meets its criteria to be considered a life-extending treatment at the end of life.


AstraZeneca has announced positive results from a Phase III trial evaluating its PD-L1 inhibitor Imfinzi (durvalumab) and anti-CTLA4 antibody tremelimumab in patients with metastatic non-small cell lung cancer (NSCLC). In the trial, patients receiving a short course of five cycles of anti-CTLA4 antibody tremelimumab over 16 weeks in addition to Imfinzi and chemotherapy demonstrated a 23% reduction in the risk of death compared to a range of chemotherapy options.


A new formulation of Chiesi’s Procysbi (mercaptamine) has been rejected by the SMC for use in patients with the rare inherited condition nephropathic cystinosis. In a statement, the SMC said the therapy could not be recommended as the company’s evidence was ‘not strong enough’ to satisfy the committee that it offers value for money to NHS Scotland compared to the current treatment.


Sanofi has announced that its investigational oral Bruton’s tyrosine kinase (BTK) inhibitor rilzabrutinib failed to meet the primary and secondary endpoints in a Phase III trial. The primary endpoint of the PEGASUS trial was complete remission from weeks 29 to 37 with minimal doses of corticosteroids. Results from the late-stage trial showed that the proportion of rilzabrutinib-treated patients who met this primary endpoint was not significantly different from placebo.


Takeda’s Phase III PANTHER (Pevonedistat-3001) study did not achieve its primary endpoint of event-free survival (EFS), the Japan-headquartered pharma company announced. The late-stage trial evaluated whether the combination of NEDD8-activating enzyme (NAE) inhibitor pevonedistat plus azacitidine as first-line treatment for patients with higher-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukaemia (CMML) and low-blast acute myeloid leukaemia (AML) improved EFS versus azacitidine alone.